Supervisor, Quality Control
10770 Wateridge Circle, Ste 200
San Diego, CA 92121
IT Support Administrator
TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.
TriLink BioTechnologies, a Maravai LifeSciences company, is seeking a Supervisor, Quality Control to join our growing team. This role is responsible for supervising quality control activities, specially raw materials, in-process, and finished good testing. Responsible for coordinating activities to ensure raw materials, in-process and finished products are released in a timely manner.
- Supervise QC Functional and Analytical teams daily activities
- Responsible for analytical data review and approve
- Responsible for production batch record review, incoming raw material release, and final product release for GMP and non-GMP from Quality Control
- Participate in method qualification as SME on data review
- Conduct quality investigations to assess root cause, corrections, corrective actions, preventive actions, and monitor effectiveness
- Use of quality tools, such as 5-Why's, FMEA's, DMAIC, Cause and Effect Diagrams, Process Mapping, etc.
- Coordinate onboard and qualify new equipment and processes
- Support and follow up on client request
- Generate, review, and revise quality system procedures, as appropriate.
- Manage contract laboratory testing
- Assist in internal and external audits, as necessary
- Maintains a safe and clean work environment by following current good manufacturing practices (cGMP), 5S and standard operating procedures. Assure compliance with all in-house or external specifications to standards
• BS Degree or equivalent in a scientific discipline
• A minimum of 5 years of experience in a quality role or equivalent in the biotechnology industry
• A minimum of 1 year in a supervisor role
• Strong organizational skills and attention to detail
• Detailed oriented professional with strong verbal and written communication skills
• Knowledge of ISO 9001 and GMP requirements (e.g. ICH Q7, 21 CFR 211, or 21 CFR 820) a plus
• Self-motivated and able to organize and prioritize multiple tasks
• Identify quality issues/discrepancies and effectively resolve discrepancies within the organization
TriLink BioTechnologies is a rapidly growing biotech firm in San Diego, CA, that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.
TriLink BioTechnologies is an EEO employer.
How to Apply
About Our Organization
TriLink BioTechnologies, a Maravai LifeSciences company, offers mRNA and oligo solutions as comprehensive CDMO services and an expansive stocked menu - to accelerate research, diagnostic, and therapeutic applications. TriLink has paved the way with industry-leading technology, consistent high quality, and ready access to expert scientific support.