EntroGen is seeking a Quality Control Scientist who will be responsible for independently performing routine quality control procedures. 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, reviewing batch records for accuracy, assuring cGMP compliance, batch releasing final product, 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.
- Lead, initiate, record, and investigate out of specification results, deviations, and NCRs.
- Develop, write, approve, implement, and monitor effectiveness of CAPAs.
- Batch release final products and raw materials and create COAs.
- Monitor and trend data for continuous process improvement.
- Manufacture and maintain inventory of all QC samples and controls.
- Review equipment maintenance/calibration logs, batch records, COAs, QC analysis sheets, laboratory notebooks, training logs, and other documentation to ensure they adhere to cGMP standards.
- Resolve equipment, technical, process, and environmental deviations and issues.
- Develop and perform stability protocols, annual product reviews, and trending analysis.
- Perform routine equipment maintenance and calibration.
- Write, review, and revise SOPs.
- Write, review, and implement method and process validation/qualification protocols.
- Manage the transfer of products and methods from R&D to QC.
- Develop in-process and final product specifications and acceptance criteria.
- Review design control documents.
- Present updates at weekly meetings.
- Train and provide support to QC team.
- Assist in internal audits of the QC and production department.
- Coordinate with production and shipping to meet customer orders and specifications.
- Perform routine laboratory tasks and provide support to scientific staff.
- Other duties as assigned.
Qualifications and Required Skills
- Bachelor’s or Master’s of Science in biology, molecular biology, biochemistry or other life science.
- 5+ years of previous laboratory experience.
- 3+ years experience in a quality control position and/or a cGMP manufacturing environment.
- Hands-on experience with qPCR.
- Proven ability to think critically, troubleshoot routine laboratory tests, and make decisions independently and in a team setting.
- Proven ability to work independently with minimal supervision.
- Ability to follow written SOPs with a high degree of accuracy.
- Proven ability to communicate clearly and effectively.
- Ability to manage one’s time, meet deadlines, and adapt to changing priorities.
- Excellent organizational skills, attention to detail, and flexibility.
- Above average computer skills.
- Knowledge of ISO13485/FDA 21 CFR Part 820 Quality Systems, ICH, and FDA requirements is highly desired.
- Solid understanding of analytical method validation and process validation (IQ, OQ, PQ).
- Solid understanding of cGMP compliance, GLP, and good documentation practices.
- Solid understanding of statistical analysis used in quality control procedures.
- Hands-on experience with taqman-probe based qPCR, library preparation, and NGS methods.
- Solid understanding of molecular biology.
- 1+ years of molecular diagnostic experience in industry or a clinical lab.
Must be authorized to work in the U.S. No relocation assistance provided. No agencies.
Please send resume and salary history to email@example.com. 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.