Our client is looking for a Principal Quality Control Analyst for their Exton PA offices.
- Perform QC Biochemistry analyses of recombinant therapeutic proteins produced at the Biologics Pilot Plant.
- Execute all assay types with uniform skill, and operates most types of analytical instruments and equipment in the department following written procedures.
- Participate in assay validations and qualifications, perform biennial document reviews, and make necessary revisions to SOPs.
- Assist with training new analysts, peer-reviews other analysts’ documentation and results for completeness, and initiates and participates in laboratory investigations.
- Generate compliant laboratory data for release, assessment of stability, validation of assays, and support of process development.
- Perform assays and techniques involving HPLC, capillary electrophoresis, ELISA, qPCR, and/or other protein analytical technologies, executing all of the techniques used in the department with equal proficiency.
- Participates in assay qualifications.
- Assist with training new analysts.
- Perform biennial SOP reviews and make needed revisions.
- Peer-review documentation and results from other analysts for completeness.
- Order supplies, clean equipment, organize common areas and stocks.
- Initiate and participate in laboratory investigations.
- Provide accurate, GxP-compliant analyses of clinical biopharmaceutical products, helping to ensure timely lot release of product.
- Ensure that analytical methods are appropriately qualified or validated, ensuring smooth regulatory approvals.
- Help maintain the biochemistry laboratory systems, will train other analysts, maintain SOPs and other documents, and promote an efficient laboratory workplace.
- Minimum of 3-5 years working experience in a cGMP Quality Control, analytical development, analytical transfer or validation department in a FDA-regulated industry.
- Exhibits understanding of the principles, concepts, and practices in QC testing of biopharmaceuticals.
- Hands-on experience in HPLC, capillary electrophoresis, ELISA, and gel-based assays for analysis of recombinant proteins.
- Experience working under cGMP regulations and with ICH/FDA/EMA guidelines.
- Ability to identify and investigate assay and equipment problems.
- Fluent in English, good written and oral communication skills; good interpersonal skills.
- Team player who can excel in a “hands-on” entrepreneurial environment.
- Physical requirements: handling of laboratory equipment, chemicals, and biological materials.
For more info on this & other exciting roles please contact me
MARC LEVINE C: 914-262-5142 E: email@example.com
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.