Career

Opportunities

JOB DESCRIPTION:

JOB TITLE: Validation Engineer

DEPARTMENT: Quality Assurance

SUPERVISOR: Validation Manager

Description:

Norac Pharma is seeking a highly motivated individual with proven technical ability, strong communication skills, and accomplished problem solving acumen to join us as a Validation Engineer. You will develop and execute scientific tests and experiments for equipment, computerized systems, and cleaning processes to generate data required to prove compliance with regulatory and internal company standards in order to produce quality API products. You will work with cross functional groups to meet validation and metrology requirements and ensure Norac Pharma meets all of its quality and operational requirements. This role will be a dynamic and critical hands-on resource reporting to the Validation Manger.

Responsibilities:

  • Responsible and accountable under the guidance of the Validation Manager to perform the validation of computerized systems, equipment, facilities, and cleaning processes.
  • Utilize measuring equipment and computerized systems in the field to perform the execution of validation protocols, re-qualifications, calibrations, and preventative maintenance.
  • Administer the Norac Pharma Work Order system. Review and approve completed work orders, PMs, temperature mappings, and calibrations.
  • Develop and deliver a complete package of validation documents and system-specific SOPs using GAMP methodology including: User, Functional and Design Specifications, Validation Project Plans (VPP), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Computerized Systems Validation (CSV), Final and Technical Reports, Risk Assessments and Failure Mode Effects Analysis (FMEA), Change Management Test Protocols, Administration and User SOPs, Work Instruction (WIs), and Forms.
  • Responsible for face to face interface and coordination with QC and Manufacturing to execute qualifications for laboratory instruments, equipment, computerized systems, and cleaning validation.
  • Maintain cGMP computerized system requirements and Quality Assurance computerized systems databases to meet all regulatory requirements and ensure efficient user workflows. Develop and assist in the configuration of new Quality Assurance computerized systems and qualify enhanced functionality and upgrades.
  • Responsible for implementing cGMP quality requirements for computerized systems throughout the organization. Define, implement, configure, maintain, and qualify computerized systems and applications as assigned by the Validation Manager. Perform computerized system risk assessment. Develop cGMP computerized systems testing protocols, execute test scripts, and communicate project progress to Validation Manager throughout the computerized systems validation lifecycle.
  • Qualify cleaning processes to meet all regulatory requirements and ensure efficient API manufacturing. Assist in establishing, maintaining, and monitoring cleaning processes.

Job duties:

  • Execute validation responsibilities and projects assigned by Validation manager.
  • Perform and plan validation and calibration tests assigned based upon project and manufacturing schedules.
  • Identify and resolve non-conformances/deviations. Perform investigations and implement corrective actions related to CAPAs.
  • Integrate vendor generated and/or performed qualifications into an overall equipment qualification that meets Norac Pharma cGMP requirements.
  • Develop, maintain, and administer changes to cGMP computerized systems including revision of specifications, risk assessments, and system operating procedures.
  • Determine customer requirements to develop hardware and software specifications.
  • Analyze and configure cGMP computerized systems including: concept, design, fabrication, test, installation, operation, data integrity, maintenance, and decommissioning.
  • Guide the identification of risks and the development of mitigation strategies for cGMP systems through risk assessment.
  • Ensure the logical and systematic conversion of Norac Pharma requirements into qualified system solutions that acknowledge technical, schedule, and cost constraints.
  • Provide technical support and perform training throughout Norac Pharma for cGMP Computerized Systems.
  • Perform validation assessments and execute qualification test plans on changes to equipment and computerized systems.
  • Other duties as assigned.

Education / Experience / Personal Requirements:

  • Strong technical writing skills required.
  • BA/BS degree in Chemistry, Engineering, Life Sciences or other science degree with 2+ years of validation experience in the biotechnology, pharmaceutical or medical device industry or equivalent.
  • Validation experience in a cGMP environment (IQ, OQ, PQ) is essential; specific computerized system validation, equipment qualification, and cleaning validation experience is strongly preferred; additional engineering, laboratory, and validation experience is a plus.
  • Demonstrated exposure to a broad range of cGMP Quality Systems such as validation, change control, documentation tracking, analytical testing, and pharmaceutical manufacturing.
  • Strong working knowledge and experience in designing test scenarios and test scripts, compiling test results, and creating documentation. Knowledge of FDA requirements for computerized systems, including 21 CFR Part 11, EU GMP Annex 11, and cGMP practices.
  • Ability to work at the place of manufacturing/operations/QC including the carrying of test equipment/materials up to 25 lbs and the scaling of ladders. Available for weekend and off shift work as required.
  • Well-developed computer skills and fluent with productivity programs and computerized database systems.
  • Knowledge and experience with GAMP's approach to validation.
  • Strong verbal and written communication skills. Can work well in a team environment to achieve results.
  • Recognizes computer software problems, can investigate problems and take appropriate steps to resolve and communicate issues. Recognizes technological limitations and addresses them.
  • Ability to understand business and technical requirements. Exhibits sound scientific judgment based on reasonable assumptions and available information.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities. Ability to function efficiently and independently in a changing environment.
  • Self-motivated and willing to accept temporary responsibilities outside of initial job description.
  • Ability to think critically, and demonstrated troubleshooting and problem solving skills.

--------------------------------------------------------------------------------------------------------

JOB DESCRIPTION:

JOB TITLE: Quality Control Laboratory Associate

DEPARTMENT: Quality Control

SUPERVISOR: Quality Control Team Leader

Description:

The Quality Control Laboratory Associate will be called upon to support and maintain the Quality Control Laboratory.

Responsibilities:

  • Responsible for removal of solvents and solid chemical waste from the laboratory area
  • Chemical inventory and ordering of material and general lab supplies.
  • Washing glassware.
  • Chemical sampling within the facility
  • Assist in non-instrumental (physical) testing of raw materials and general lab assistance.
  • Lab housekeeping.
  • Daily routine lab inspection.
  • Other duties as assigned by the QC Team Leader.

Education / Experience / Personal Requirements:

  • Requires a minimum of a High School Diploma.
  • General knowledge of chemistry and/or familiarity with handling chemicals.
  • Experience in a cGMP Laboratory environment.
  • Moderate lifting, moving of gas cylinders and climbing ladders.
  • Good verbal and written communication skills required.
  • Able to carefully follow detailed instructions.

--------------------------------------------------------------------------------------------------------

JOB DESCRIPTION:

JOB TITLE: Quality Assurance Specialist

DEPARTMENT: Quality Assurance

SUPERVISOR: Quality Assurance Manager

Description:

The Quality Assurance Specialist will support the Quality Assurance department and the entire organization with review of Production Batch Records and Analytical Test Reports and release of raw materials. This position additionally will support Regulatory Affairs with document review, analytical calculations, organization, and assembling documents for regulatory submissions. Furthermore, this position will be involved in the quality oversight for the manufacture, testing and release of finished Active Pharmaceutical Ingredients.

Responsibilities:

  • Under the direction of the Quality Assurance Manager, the Quality Assurance Specialist ensures that applicable cGMP requirements are being met by all departments engaged in the development, manufacture, processing, packing, analysis, holding, or distribution of product.
  • Organize and perform review of Production Batch Records and Analytical testing reports to ensure timely release of finished API’s.
  • Perform production line clearance and assist in investigative documentation.
  • Perform label and final product inspection.
  • Review raw material data package for release
  • Apply approved label on released raw materials and final product.
  • Develop any needed procedures for the Quality Assurance Unit.
  • Assist the Quality Assurance Manager in other QA related activities.
Job Duties
  • GMP understanding, awareness, and enforcement.
    • Duties include constant awareness of GMP behavior throughout the facility and documentation.
    • Report any and all GMP deficiencies immediately to the QA Manager.
  • Ensure that employees within their respective section(s) comply with the current Good Manufacturing Practices.
  • Review and release intermediates and finished product analytical reports and batch records.
  • Review and approval of monitoring data (e.g., stability, water system, solvent system).
  • Review of raw material release package
  • Inspection, verification, and issuance of all labeling and artwork.
  • Write and revise documentation, when appropriate.
  • Participate in Quality Review Report distribution.
  • Perform other QA related functions as directed by the Quality Assurance Manager.

Education / Experience / Personal Requirements:

  • A Bachelors Degree in a scientific discipline is required, preferably Chemistry.
  • Minimum five years experience in a Quality Assurance or Quality Control position in a GMP environment, preferably API manufacturing facility.
  • Proficient in Microsoft Office applications (advanced knowledge of MS Word and Excel is preferred).
  • MasterControl experience is highly desired.

--------------------------------------------------------------------------------------------------------

JOB DESCRIPTION:

JOB TITLE: Chemist II Process Research and Development

DEPARTMENT: Process Research and Development

SUPERVISOR:Senior Chemist, Senior Chemist I, Senior Chemist II, Projects Leader, Projects Leader I, Projects Leader II, Principal Scientist, Senior Principal Scientist, Process Research and Development

Description:

The Process Research and Development Chemist will perform synthetic chemistry experiments to assist in developing and validating process chemistry for new and/or established products and projects, characterizing reaction products and intermediates with appropriate methods and maintaining laboratory records in accordance with cGMP/GLP practices and requirements.

Responsibilities:

  • Primary Responsibilities:
    • Assist and contribute to developing and validating new process chemistry and exploiting and validating established process chemistry for synthetic organic chemical reactions.
    • Generate unforeseen insights into chemical reactions and procedures under development.
    • Some mentoring of junior staff.
    • Assist and contribute with the scale-up of new products from gram quantities to production quantities.
    • Reasonable ability to interpret data via modern spectroscopic tools (IR, NMR (H,C,1-D,2-D), UV-Vis, MS)
    • Prepare novel compounds with optimized chemical and/or physical properties.
    • Generate gram quantities of high-purity samples of key intermediates, most often by chromatography, recrystallization, and/or ambient/reduced pressure distillation.
    • Obtain scale-up kinetic and thermodynamic experimental data involving controlled variables by performing periodic removal, quenching (if required) and analysis of aliquots.
    • Perform routine characterization of reaction products and intermediates by both wet and instrumental methods.
    • Ability to distinguish between expected and unexpected experimental results.
    • Maintain laboratory records in accordance with accepted cGMP/GLP laboratory practices, SOPs, and regulatory requirements.
    • Assist with the preparation / review of GMP-related (i.e., controlled) documentation.
    • Adheres to current Good Manufacturing Practices (cGMP’s).
    • Ability to write detailed reports and present results to upper management and clients when required.
  • Safety Responsibilities:
    • Actively support the Environmental, Health & Safety programs of Norac Pharma to ensure employee and plant safety and security.

Education / Experience / Personal Requirements:

  • B.Sc. in Chemistry (or equivalent) with 5+ years of experience
  • M.Sc. in Chemistry
  • Experience with basic chemistry laboratory technology and practical hands-on knowledge of general chemistry.
  • Detailed experience in scale-up of a variety of synthetic organic transformations.
  • Knowledge of broad based cGMP/GLP principles and the ability to apply said principles is helpful.
  • Ability to perform a range of chemical calculations.
  • Practical experience in the techniques and procedures of modern organic chemistry including spectroscopy, chromatography, handling air-sensitive agents, etc.
  • Basic computer literacy (knowledge of Excel or other spreadsheet programs recommended).
  • A high degree of patience.
  • A strong commitment to mastering advanced laboratory techniques.
  • Good interpersonal skills in a decentralized environment.
  • A careful observer dedicated to maintaining professionally valid records including lab notebooks.
  • Intellectually inquisitive.
  • Able to manage multiple tasks and prioritize work.
  • Self-motivated with strong time management skills.

--------------------------------------------------------------------------------------------------------

JOB DESCRIPTION:

JOB TITLE: Chemist I Quality Control

DEPARTMENT: Quality Control

SUPERVISOR: Team Leader Quality Control

Description:

The Quality Control Chemist I will perform release testing at all stages of chemical manufacture including raw material, in-process and finished product as well as perform analytical method validation, cleaning verification and stability testing according to newly developed and established protocols as well as assisting Analytical R & D Chemists to develop analytical methods suitable for validation on an as-needed basis.

Responsibilities:

  • Testing of raw material, in-process, and finished product in support of commercial manufacturing and contract projects using analytical instrumentation and wet chemical tests.
  • Determination of assay, organic impurities, residual solvents, water content and inorganic impurities of molecule of interest using wet chemical analytical methods and LC, GC, IC, etc analytical instruments
  • Characterization of chemical impurities and reference standards
  • Generation of method validation protocols and perform validation experiments
  • Documentation of developed analytical methods, including, but not limited to documentation within the laboratory notebook and method creation within EDMS
  • Document and maintain data from testing of chemical raw materials, in-process material and products as per Good Documentation Practices procedure
  • Prepare and execute stability protocol, initiate stability study and prepare interim and final reports detailing results of protocol execution.
  • Perform cleaning method validation and write cleaning validation reports.
  • Perform the following as needed:
    • Method transfer in-house and from clients
    • Method verification
    • Evaluate and validate client methods
    • In house methods validation, including contract and commercial products
    • Material and standard qualification
    • Routine lab instrument calibration
  • Peer review of lab notebooks, validation and stability reports for calculations and accuracy of results.
  • Perform day to day general lab activities e.g. sampling of solvents for monitoring purposes, cleaning lab glassware, monitoring stability chambers, maintaining cleanliness in the laboratory
  • Write validation and stability reports and memos
  • Perform biennial document review and revise documents as deemed necessary
  • Create new methods and SOPs as necessary
  • Train junior staff on equipments and software usage
  • Compliance with company, legal and regulatory procedures and standards

Education / Experience / Personal Requirements:

  • Degree in chemistry and/or chemistry analytical science with 0 to 2 years of quality control, pharmaceutical process analytical chemistry experience
  • Hands-on working experience of Laboratory Instrumentation (HPLC’s, GC’s, GCHeadspace, Ion Chromatography, NMR, FTIR, UV-Vis, KF, etc.) is preferred
  • Good team working skills and experience
  • Ability to work as part of a multi-functional project team involving quality control staff, process analytical chemist(s), process development chemist(s), and chemical production staff
  • Knowledge of broad based cGMP/GLP principles and the ability to apply said principles is helpful.
  • Ability to perform a range of chemical calculations.
  • Practical experience in the techniques and procedures of modern organic chemistry including spectroscopy, chromatography, handling air-sensitive agents, etc.
  • Knowledge of current Good Manufacturing Practices for pharmaceutical chemical manufacture.

    --------------------------------------------------------------------------------------------------------

JOB DESCRIPTION:

JOB TITLE: Accounting Clerk

DEPARTMENT: Accounting

SUPERVISOR: Accounting Manager

Description:

The Accounting Clerk’s main role is to ensure that new project budgets and billing milestones are set up in the various tracking systems upon customer approval of project proposal; Project progress is monitored in collaboration with project leaders and customer invoices are issued according to set milestones. Projects are then closed when all deliverables have been completed and final invoices issued.

Responsibilities:

  • Track contract service project milestones including project materials.
  • Monitor project spending variances and report to project managers.
  • Invoice customers - anticipate dates of completion verify milestone completion and prepare and issue invoices upon approval.
  • Review “5180 – Reimbursable project expenditures” worksheet. Analyze vendor invoices to ensure proper project coding and make adjustments for sales taxes if required. When invoicing client add a 5% administrative fee where appropriate.
  • Review “5190 - Non-reimbursable project expend” worksheet. Confirm that charges are not billable to the project.
  • Prepare and issue project reports to Project Leaders for review. Solicit feedback on project status and hours to completion. Include project materials tracking information.
  • Monitor customer accounts receivable. Contact customers regarding past-due invoices and report collection status to management (i.e. Portfolio meeting, emails, etc).
  • Prepare billing update reports. Flag overdue items and note follow-up actions.
  • Responsible point person and coordinator for all shipments of Commercial and Contract Pharma products. Communicate shipment confirmation & receipt notification via email to stakeholders both internal and customers.
  • Fulfill Customer Service tasks including:
    • Order entry
    • Coordinate with production, QC Group (for COAs) and shipping.
    • Provide shipping paperwork packet 2 days prior to pick up.
    • Contact customers regarding meeting delivery requests.
    • Provide post ship documents as required.
  • Maintain and update CISPro (PRD chemical inventories and software system).
  • Upload new CDAs into the EDMS system and file paper copies. Archive expired CDAs in EDMS as required.
  • Update the QuickBooks Enterprise system with new Pharma products, customers and contracts.
  • Summarize and maintain customer agreements for Contract Pharma noting all billing milestones, amounts, expense reimbursement and expense reimbursement limitations and amendments to the contracts. Report status of all contracts on a periodic basis.
  • “Completed Project and Percentage Completion Analysis report” – update data elements monthly: Add new projects, update budget hours, spent hours, hours to complete, milestones invoiced, materials expense(both 5180 and 5190), etc.
  • Set up charge codes spend vs. budget and billing milestone summary in charge code spreadsheet.
  • Portfolio meeting: prepare and present draft project slides at monthly meeting and circulate post-meeting action items and notes.
  • Cover front desk (greet/safety paperwork, answer phones, monitor staff going off site, etc.) when the receptionist is absent or at lunch.

Education / Experience / Personal Requirements:

  • 2 years experience in an administrative, clerk or bookkeeping role
  • Accounting/Bookkeeping coursework, preferred
  • Excellent problem solving, computer and Microsoft Office skills
  • Extremely detailed oriented and organized

--------------------------------------------------------------------------------------------------------

Thank you for your interest in Norac Pharma however we regret that we are unable to acknowledge all submissions and only those candidates who we invite for interview will be considered to be confirmed applicants.