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Quality Control Technician

Repligen Marlborough, MA

  • Posted: over a month ago
  • $40,000 to $52,000 Yearly
  • Full-Time
  • Benefits: vision, 401k, dental, life insurance, medical,
Job Description

The QC Technician will be responsible for performing in-process testing and data collection of flat sheet membrane and tangential flow filtration cassettes.  The analytical equipment you will be using to support this position includes spectrophotometer, balance, pipette, pressure gauges, timers, and stirred cells.  The successful candidate will actively follow Repligen ISO 9001 Quality Management System in support of the manufacturing processes and final product testing, including additional laboratory compliance as assigned by the QC Supervisor. Training will be on the first shift for approximately 6-8 weeks prior to transitioning to second shift. 1st Shift: 6:30 a.m. - 3:00 p.m; 2nd Shift: 3:00 p.m. – 11:30 p.m.

Cassette Testing:

  • Performs final test integrity and pressure drop performance for each cassette in accordance with established procedures and limits
  • Document test results, process batch records and records summary results in applicable spreadsheet for trend analysis
  • Flush and sanitize each cassette filter transferred from cassette assembly
  • Will assist in OOS investigations, NCMR’s, deviations, and customer complaints

Membrane Testing:

  • Performs marker testing: passing, retaining, and water flux, of flat sheet membranes in accordance with established procedures and limits
  • Document test results, process batch records and records summary results in applicable spreadsheet for trend analysis
  • Support membrane manufacturing activities as directed by the membrane manufacturing group
  • Will assist in OOS investigations, NCMR’s, deviations, and customer complaints

Other Functions:

  • Maintain cleanliness of lab and test equipment as well as monitor calibration schedule of equipment
  • Interface with QA representative and production personnel to maintain flow of product, as well as to identify non-conforming products
  • Meet target of intermediate and long term goals established by management. Long term goals will be established annually and followed by both the employee and management throughout the year.
  • Assist with the training of new hires in following procedures related to test methods used in performing their job
  • Must be able to follow oral and written instructions accurately, learn complex tasks quickly, and complete tasks in a timely manner
  • Must be able to write clearly and accurately on data sheets, logs and other documentation
  • Candidates must be willing and able to learn new manufacturing processes as the company grows and to work overtime (including weekends).

Qualifications:

  • Requires a high school diploma with 2-4 years experience in a QC laboratory or equivalent, or college degree with 0-2yrs experience. 2-yr college level education in biology, or other science related field preferred.
  • Ability to work efficiently in an ISO-9001 quality system with appropriate attention to detail in the performance of controlled procedures.
  • Good working knowledge of MS Office, especially Excel
  • Ability to work independently once training has been completed
  • High attention to detail applied to all aspects of daily activities
  • Excellent organizational and communications skills
  • Must be resourceful and self-motivated
  • Must be capable of lifting up to 50 lbs.
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

111 Locke Drive

Marlborough, MA
01752 USA

Industry

Manufacturing

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