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Supervisor, Quality Control

Organization

TriLink Biotechnologies

Job Location

10770 Wateridge Circle, Ste 200
San Diego, CA 92121
United States

Job Description

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.

Responsibilities

  • 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

Qualifications

•  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

https://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=ed2438b9-d7f4-45be-b3d8-8c924068c18a&ccId=2036080543_6069&jobId=332323&source=CC2&lang=en_US

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.