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Quality Engineer I Complaints

Repligen
Marlborough, MA
  • Posted: over a month ago
  • $90,000 to $100,000 Yearly
  • Full-Time
  • Benefits: vision, 401k, dental, life insurance, medical,
Job Description

The Quality Engineer will report directly into the QA Manager or Director.

This position is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible for providing support and investigation of customer complaints for commercial products and supporting continuous improvement of commercial products.

This position will participate in receiving, reviewing, and processing product and customer complaint handling and risk management, as well as additional departmental support.

 

Responsibilities:

• Interface with customers regarding the details and documentation of complaint records, investigation, and risk management
• Responsible for collecting data related to product complaints and entering collected information into the complaint management system
• Immediately notify senior management of Complaint Management issues that suggest a potential regulatory or business risk
• Request and document any additional information needed to thoroughly evaluate and investigate the complaint, including coordinating the procurement of complaint samples
• Send written or electronic acknowledgement of the complaint to the customer
• Document all contact with complainants in the system
• Manage workload to ensure complaint completion within targeted turn around time
• Ability to establish rapport with internal/external customers, peers, and employees in all departments
• Support activities and documentation related to corrections, corrective actions and preventive actions to correct and eliminate the potential for non-conformances
• Works constructively with cross-functional departments for timely resolution of quality issues

Qualifications/Skills

• BA/BS degree (in a Biological Science, Engineering, or Physical Science requires).
• Experience with stainless steel and plastic device, systems/software and consumable products and associated manufacturing processes.
• Minimum 2-4 years working in a regulated environment, preferably in Bioprocessing

• Experience with Quality Management System (ISO 9001)
• Customer service/complaint handling and problem-solving skill
• Basic computer skills (i.e. Microsoft Office - word processing, spreadsheets, databases); SalesForce, Canea One experience preferred
• Documentation, negotiation, time management, and communication skills (both written and verbal)
• Reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems/conflicts
• Must be extremely detail-oriented

  • Certified Six Sigma Green Belt
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

Marlborough, MA
USA

Industry

Manufacturing

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