Vacancy: Supervisor, Quality Control, San Diego, CA, USA

Vacancy: Supervisor, Quality Control, San Diego, CA, USA

Posted on: Aug.26.2021

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies, a Maravai LifeSciences company, is seeking a Quality Control Supervisor to join our growing team. This role is responsible for supervising quality control activities, specifically raw materials, in-process and finished good testing. Responsible for coordinating activities to ensure raw materials, in-process and finish products are released in a timely manner.


Responsibilities

-Supervise QC Functional and Analytical teams daily activities
-Responsible for analytical data review and approval
-Responsible for production batch record review, incoming raw materials release, and final product release for GMP and non-GMP for Quality Control
-Participate on method qualification as SME on data review
-Conduct quality investigations to assess root cause, corrections, corrective actions, preventive action, and monitor effectiveness. Use of quality tools, such as 5-Why’s, FMEA’s DMAIC, Cause and Effect Diagrams, Process Mapping, etc.
-Coordinate onboarding 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 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 the 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 (EG. ICH Q7, 21 CFR, OR 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.




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