Proclinical is currently recruiting for a QC Analyst with a pharmaceutical company located in Gaithersburg, MD. We are seeking an Experienced Quality Control Analyst to join our Quality Control team. Qualified individuals will be responsible for performing assay qualification and validation as well as analytical testing on in-process samples, drug substance and drug product for release and in support of stability studies.
- Performs GMP release and stability testing in Quality Control
- Analytical methods include: UV Spectroscopy, RP-HPLC, BCA, qRT-PCR, ELISA, SDS-PAGE, Capillary Electropheresis
- Ensure that written records and work undertaken are performed in accordance with cGMP and company procedures
- Participates actively in technology transfer, method qualification and validation
- Keeps accurate testing records and assures that laboratory equipment has been calibrated, standardized, and monitored as appropriate
- Assists in the writing, reviewing and editing of standard operating procedures
- Write technical reports and supporting documentation such as deviation, CAPAs, reports, testing protocols, and trend analyses
- Performs root cause investigation and analysis
- Participates in continuous improvement projects
- Assist in the maintenance of the lab including routine housekeeping activities
- Maintain effective communication with other relevant groups, including but not limited to Quality Assurance, Manufacturing and Analytical Development
- Other duties as assigned
Skills and Requirements:
- Bachelor's degree in Biology, Molecular Biology, Biochemistry, Chemistry, Life Sciences, or other related discipline
- Minimum of 5 years years of related experience working in a quality control laboratory environment
- Knowledge and expertise in principles and practices of current Good Manufacturing Practices (GMPs)
- Excellent analytical skills and knowledge
- Strong troubleshooting skills for equipment and software
- Excellent communication/interpersonal and presentation skills
- Experienced with EHS guidelines in a laboratory environment
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at 267-428-7770.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.