EntroGen is seeking a Quality Control/Quality Assurance Associate who will be responsible for routine quality control procedures under general supervision. The main responsibilities of this position include performing routine testing of raw materials, in-process samples, controls, and finished product, writing protocols and reports, compiling data into comprehensive packages, packaging and inspecting products, reviewing batch records for accuracy, assuring cGMP compliance, and writing/revising SOPs. This position will also provide support to manufacturing and production as needed.
Essential Duties and Responsibilities
- Collect samples, perform batch QC, analyze data, and generate reports for routine analytical testing of raw materials, in process samples, finished products and QC materials.
- Initiate, record, and investigate out of specification results and NCRs.
- Develop, write, approve, implement, and monitor effectiveness of CAPAs.
- Manufacture and maintain inventory of all QC samples and controls.
- Review equipment maintenance/calibration logs, batch records, QC sheets, laboratory notebooks, training logs, packaging checklists, and other manufacturing and quality documentation to ensure they adhere to cGMP standards.
- Perform routine equipment maintenance and calibration.
- Screen incoming samples.
- Write, review, and revise SOPs.
- Perform analytical, method, and process validation and qualification during the transfer of products from R and D to production/QC.
- Perform routine laboratory tasks and provide support to scientific staff.
- Provide support to production/manufacturing activities in and out of the clean room.
- Assist in internal audits of production and QC departments.
- Other duties as assigned.
Qualifications and Required Skills
- Bachelor’s or Master’s of Science in molecular biology, biology, biochemistry, or other life sciences.
- 2+ years of previous laboratory experience.
- Hands-on experience with PCR (PCR/qPCR).
- Proven ability to think critically and troubleshoot routine laboratory tests.
- Ability to follow written SOPs with a high degree of accuracy.
- Proven ability to communicate clearly and effectively.
- Ability to adapt to changing priorities.
- Excellent organizational skills, attention to detail, and flexibility.
- Must possess above average computer skills.
- Knowledge of ISO13485/FDA 21 CFR Part 820 Quality Systems, ICH, and FDA requirements is highly desired.
- Solid understanding of cGMP compliance and good documentation practices.
- 1+ years experience in a quality control position and/or a cGMP manufacturing environment.
Must be authorized to work in the U.S. No relocation assistance provided. No agencies.
Please send resume and salary history to firstname.lastname@example.org. No agencies, please.
EntroGen is a biotechnology company with a focus on molecular diagnostic products in the areas of hematology and oncology. EntroGen has a growing commercial portfolio of real-time PCR-based tests, with many of its products being used to guide and monitor targeted therapies for various malignancies. EntroGen’s footprint reaches every corner of the globe delivering reliable clinical and research products