GMP QC Analyst III - Contract - Lexington, MA
Proclinical is seeking a dedicated GMP QC Analyst III to join our client's team in Lexington, MA.
Primary Responsibilities:
The successful candidate will be instrumental in maintaining high standards of quality and compliance from development through commercialization. You will perform both routine and non-routine testing, participate in data trending, and support laboratory operations. Your contributions will be vital in method transfers, qualifications, and validations, ensuring the efficiency and effectiveness of our Quality Control functions.
Skills & Requirements:
- Degree in chemistry, biology, biochemistry, or related field.
- Experience in GMP Quality Control within the pharmaceutical/biotech industry.
- Knowledge of method transfer and analytical method implementation.
- Strong technical writing skills, especially for investigations.
- Proficient in data analysis with attention to detail.
- Problem-solving skills and experience with CAPA.
- Strong organizational skills and ability to manage multiple tasks.
- Excellent communication and teamwork abilities.
- Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred.
The GMP QC Analyst III's responsibilities will be:
- Conduct routine and non-routine analytical and microbiological assays for raw materials, in-process samples, product release, and stability studies.
- Support weekend laboratory operations to maintain a continuous schedule.
- Maintain training records, adhere to testing schedules, and complete assignments timely.
- Assist in laboratory equipment maintenance and inventory management.
- Review data promptly and qualify as a data reviewer.
- Perform operational tasks such as SAP transactions and environmental monitoring.
- Update controlled documents like SOPs and test methods.
- Adhere to internal and regulatory standards (GMP, GLP, ICH guidelines).
- Engage in continuous improvement efforts for laboratory processes.
- Pursue ongoing training in QC testing techniques and regulatory compliance.
- Assist in preparing technical documentation for regulatory submissions.
- Participate in inspection readiness activities and support audits.
- Collaborate with various organizational functions to align with business goals.
If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@proclinical.com
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.
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