Quality Control Analyst I

Title:

Quality Control Analyst I Location:

Swiftwater, PA Duration:

12 Months+ Possible Extension 1st

Shift:

8-4:30 EST; Mon-Fri This position will be filled as a Sunday through Thursday position with occasional off-shift and weekend work required when necessary.

Manager Notes:

Must have a BS in any science degree . Full Onsite 0-3 years

• Must have lab experience
• ELISA testing, pipetting, excel, LIMS, etc. Preferred skills
• works well in a group setting, very fast paced lab with critical work

Description:

Perform operations necessary for quality testing and plays a role in implementing new technology within quality control. At more senior levels, provide an investigative or technological orientation in designing, executing, interpreting and validating quality procedures and test methods. Complete routine testing of raw materials, in-process and final products in accordance with SOPs for product release and validation. Aid in the development of test methods. Conduct data review and preliminary evaluation of results. Solve problems using limited predetermined options such as repeating the assay when parameters are not met to determine the cause, etc. Provide input to the technical composition of operating documentation. Work is closely supervised. Follows standard practices to obtain solutions. Contribute to the completion of routine technical tasks. Failure to achieve results can normally be overcome without serious effect on schedules and programs. Contacts are primarily with immediate supervisor and other personnel in the section or group.

Years of Experience:

0

• 3

Years Responsibility:

The Associate Quality Technician

• Quality Control candidate filling this position will perform testing in the Quality Control Bioassay laboratory while strictly adhering to site work instructions, Federal Regulations, cGMP, and Client Pasteur policies and procedures.

This position requires the individual to perform routine testing as scheduled to support production, method validation as well as the stability program and complete required documentation. They will also be required to perform cleaning of work areas, equipment, and any other jobs as required, ensure all duties are completed on time and complete required Safety and Compliance training and associated training modules as assigned. Knowledge and experience of immunology-based testing are preferred. Experience in immunological assays desired.

Key Accountabilities:

Performs current tests by strictly adhering to SOP, SWI, Federal Regulations, cGMP, training modules (when applicable), Client policies and procedures, and safety procedures. Performs testing as per the testing schedule defined by laboratory management to meet demands of Production, Methods Development, Validation, Independent Demand, and Stability program. Completes required paperwork and documentation as required. Ensures product integrity by testing products, pulling samples, placing work orders, and visual inspection of samples. Prepares for and operates QC equipment including pre and post-run setup and maintenance. Troubleshoots sample discrepancies. Performs peer proofing on assays. Maintains laboratories in a safe and compliant state.

System-related functions:

SAP (Cycle counts, confirmations, inventories, etc.), Trackwise (MDOs & IPDNs), LIMs (inventories), etc. Performs cleaning of laboratories, equipment, and ancillary areas as required. Attends/Contributes to scheduled team meetings, department meetings, and safety meetings. Document review. Safety and compliance training. Module/Assay training as assigned. Professional/Technical development training on/ off-site as assigned. Understand and support the implementation of change controls, CAPAs, and deviation corrective actions. Notifies laboratory manager of any deviations or issues and initiates incident investigations as required. Support deviations.

Qualifications:

Education/experience Bachelor's degree in a Science field ( Biology, Immunology, and related disciplines) 0

• 3 years of relevant experience (immunology, biology).

ELISA testing preferred. Good mathematical skills and computer literacy. Excellent organizational, verbal communication, and written communication skills. Ability to work efficiently with minimal error and high attention to detail. Experience directly working in a cGMP facility, including QC testing is preferred. #sczr2