Senior QA Specialist, Materials Release

Organization
TriLink Biotechnologies
Job Location
9990 Mesa Rim Rd, Ste. 110
San Diego, CA 92121
Job Description

TriLink Biotechnologies is seeking a Sr. Quality Assurance Specialist II, Material Release responsible for incoming raw material, intermediates, and consumables approval in compliance with cGMP regulatory requirements.  This role is also responsible for review and approval of batch records and final product release, in addition to, support CAPA, OOS, deviations and nonconformance investigations.  Responsibilities include:

 

  • Responsible for conducting raw material, component, in-process and final product inspection, labeling, and release
  • Review batch records for compliance to Good Documentation Practices and against established release specifications
  • Review analytical test reports in support of master batch record approval and release
  • Review and approve Certificates of Analysis and Certificates of Release/Conformance
  • Routinely review specifications/standards  inspection for compliance to current regulatory requirements
  • Support investigations of nonconforming products (NCMRs) and ensure nonconforming materials are quarantined to prevent use

 

Qualifications

  • BS Degree in scientific discipline
  • Quality professional with 2-5 years of hands on experience in review and approval of material/product release in a life science industry
  • Detailed oriented professional with strong verbal and written communication skills
  • Good computer skills with working knowledge of MS office suite and Adobe Acrobat
  • Self-motivated and able to organize and prioritize multiple tasks
  • Identify quality issues/discrepancies and effectively resolve discrepancies within organization


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. 

How to Apply

Please email resume to hr@trilinkbiotech.com

About Our Organization

In 1996, TriLink was founded with the goal of becoming the market leader in modified oligonucleotide manufacturing. Today, we are known throughout the world for synthesizing high quality nucleic acid and mRNA products for research, diagnostics, OEM and therapeutics. We’d like to thank all our customers for your continued confidence in our products, services and support. 

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