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QA Associate II

Organization
TriLink Biotechnologies
Job Location
9955 Mesa Rim
San Diego, CA 92121
United States
Job Description

TriLink Biotechnologies is seeking a Senior Quality Associate to join our team. The Senior Quality Associate is responsible for production batch record review and final product release from Quality Assurance. This role will ensure that final products meet all specifications prior to final product release by QA and is responsible for all aspects of Nonconforming Material Reports associated with final product and raw material.

Responsibilities

  • 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.
  • Initiation of deviations, quarantine requests or non-conforming material reports due to a non-conformance. Routing of information to appropriate departments to facilitate timely responses to non-conformances.
  • Generate, review, and revise quality system procedures, as appropriate.
  • Support other quality systems including CAPA, complaint handling, deviations, training, etc.
  • Assure compliance with all in-house or external specifications to standards.
  • Support the Raw Material Release function as required.

Qualifications

  • BS Degree or equivalent in a scientific discipline
  • A minimum of 3 Years of experience in a quality role in the biotechnology industry
  • Strong organizational skills and detail-oriented
  • Strong communication, interpersonal skills, and team player
  • Knowledge of ISO 9001 and ICH Q7 requirements
  • Ability to work independently and prioritize tasks
  • Comfortable in a fast paced, stimulating and customer-focused environment

Education

  • BS Degree or equivalent in a scientific discipline

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.

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.

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. 

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