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QA Supervisor

Repligen
Waltham, MA
  • Posted: over a month ago
  • $92,500 to $105,000 Yearly
  • Full-Time
  • Benefits: medical, vision, 401k, dental, life insurance,
Job Description

The Quality Assurance Supervisor will report directly to the QA Manager or Director.

 

This position is responsible to actively participate in the Repligen ISO 9001 Quality Management System.  This role will be responsible for the management of Quality Associates in support of product release. The QA Supervisor will manage, mentor and motivate their direct reports.  They are responsible for supervising the daily schedule and assigning tasks to their direct reports.  Must work independently and manage short and long-term priorities.

 

They will work closely with the manufacturing team assisting with Quality Management Systems such as non-conforming materials, deviations and corrective actions. Demonstrates good judgement in selecting methods and techniques for obtaining solutions.

 

This role leads the Quality Associates in the identification, review and approval of deviation investigations and Out of Specifications (OOS) results, root cause analysis and generate corrective actions to improve processes/systems.

  Knowledgeable with ELISA Test Kits and Affinity Ligands

·   Subject Matter Expert for Repligen Quality Management Systems and product line.

·   The management of timely release of finished good products.

·   Supervise direct reports which includes, setting objectives, monitoring performance and conducting reviews.

·   Works with Subject matter experts, area managers and QA personnel to effectively manage and execute follow up on corrective actions, deviations and non-conformances, complaints.

·   Assist with compliance audits (customer, supplier, internal, external).

·   Manages daily schedule and communicates with peers and management for completion of tasks associated with product release. 

·   Gathering of KPIs for weekly and monthly senior management meetings.

·   Final approval of quality investigations.

·   Assist with the Product/Process Change Control process.

·   Ability to lead quality meetings with multi-functional departments/individually to identify product.

·   Ability to identify, detect and escalate quality related trends.

·   Assist with the maintenance of the Repligen Quality Management Systems, as assigned.

Bachelor’s degree in Biological Science or other science related discipline.

·   Minimum 5-7 years’ experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent.

·   Ability to communicate with multiple departments and direct reports.

·   Proficient in written and oral presentations skills.

·   Shares timely information with peers on daily progress.

·   Ability to contribute to and lead project teams.

·   Focus and attention to detail is critical.

·   Lead/Internal auditor certification preferred.

·   Experience and knowledge of IT software platforms that support Quality Management Systems.

Understanding of Good Documentation Practices preferred.

 

Company Description
Inspiring advances in bioprocessing, Repligen is a leader in bioprocess filtration, pre-packed chromatography and Protein A ligands development. Propelled by a culture of innovation and collaboration, and with a focus on cost and process efficiencies, our people and our technologies help meet critical bioproduction demands worldwide. Named one of the fastest growing biotech companies in the USA, Repligen is headquartered in Waltham, Massachusetts with major manufacturing sites in Massachusetts, California, Sweden, and Germany. This job is located at our CA site in Rancho Dominguez.

Repligen offers the broadest range of hollow fiber and flat sheet filtration technologies for cell culture and purification, featuring XCell® ATF Systems, Spectrum® KrosFlo TFF Filters and Systems and TangenX® Flat Sheet TFF Cassettes. As the expert in pre-packed chromatography technology, Repligen offers OPUS® Pre-packed Columns with unparalleled flexibility and scalability from bench- to production-scale. Since 1985, Protein A affinity ligands manufactured by Repligen have been routinely used to purify most of the world’s monoclonal antibodies.

Repligen

Why Work Here?
We are a bioprocessing company with a diversified portfolio of leading edge solutions. Come grow with us!!

Inspiring advances in bioprocessing, Repligen is a leader in bioprocess filtration, pre-packed chromatography and Protein A ligands development. Propelled by a culture of innovation and collaboration, and with a focus on cost and process efficiencies, our people and our technologies help meet critical bioproduction demands worldwide. Named one of the fastest growing biotech companies in the USA, Repligen is headquartered in Waltham, Massachusetts with major manufacturing sites in Massachusetts, California, Sweden, and Germany. This job is located at our CA site in Rancho Dominguez. Repligen offers the broadest range of hollow fiber and flat sheet filtration technologies for cell culture and purification, featuring XCell® ATF Systems, Spectrum® KrosFlo TFF Filters and Systems and TangenX® Flat Sheet TFF Cassettes. As the expert in pre-packed chromatography technology, Repligen offers OPUS® Pre-packed Columns with unparalleled flexibility and scalability from bench- to production-scale. Since 1985, Protein A affinity ligands manufactured by Repligen have been routinely used to purify most of the world’s monoclonal antibodies.

Address

41 Seyon Street Suite 100 Waltham

Waltham, MA
USA

Industry

Technology

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