Senior Quality Assurance Associate
TriLink Biotechnologies is seeking a Senior Quality Assurance Associate to join our team. TriLink is a leader in the areas of oligonucleotide and messenger RNA manufacturing and is at the forefront of exciting new therapeutic areas such as gene editing, gene replacement and self-amplifying vaccines.
The Senior QA Associate is responsible for production batch record review, incoming raw material release, and final product release from Quality Assurance. Support CAPA, OOS, deviations and nonconformance investigations. This role is responsible for ensuring that final products meet all specifications prior to final product release including closure of deviations and non-conformances associated with the batch.
- Verification of final product, batch records, labels and associated certificates for compliance, accuracy and completeness. Verification of final product testing results with specifications to ensure all release criteria are met. Release and approval of final product from Quality Assurance.
- Responsible for conducting raw material, component, in-process and final product inspection, labeling, and release.
- Initiation of quarantine requests or nonconforming material reports due to a nonconformance. Routing of information to appropriate departments to facilitate timely responses to non-conformances.
- Review and approve Certificates of Analysis and Certificates of Release/Conformance.
- Participate in the Material Review Board regarding nonconforming or quarantine material to determine appropriate disposition of material.
- Support and follow up on client requests.
- Generate, review, and revise quality system procedures, as appropriate.
- Support other quality systems including CAPA, complaint handling, deviations, training, etc.
- Assist in internal and external audits, as necessary.
- 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 in the biotechnology industry
- Strong organizational skills and attention to detail
- Strong communication and interpersonal skills
- Knowledge of ISO 9001. Knowledge of GMP requirements (e.g. ICH Q7, 21 CFR 211, or 21 CFR 820) a plus.
- Ability to work independently and prioritize tasks
- Comfortable in a fast paced, stimulating and customer focused environment
TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefit package including medical, dental, vision, LTD, and a retirement plan.
TriLink is an EEO Employer.