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Biomanufacturing QA Floor Support

Devens, MA 01434

Posted: 07/25/2023 Job Number: 24549065

Job Description

This role is 100% Onsite!

Pay ranges between $56.50 - $61.33 an hour!

NOTE: Manger looking for a candidate with more Quality Experience: Batch Records, Non-Conformance processes. Not looking for a person with Lab Experience.

Required Skills:
  • Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
  • A minimum of 6-10years of relevant experience in a regulated environment with 2-4 years focused on product quality preferred.
  • Demonstrated ability to independently assess complex manufacturing and automation issues.
  • Knowledge of biotech cell culture, protein purification, bulk and finished product manufacturing is required.
  • Knowledge of US and EU cGMP regulations and guidance.
  • Knowledge of manufacturing batch record execution and review, maintenance execution approval, inventory management, and deviation management and approval are desirable.
  • Work Schedule is: 5AM - 5PM, 12-hour shift; working B1 Crew; schedule is like a " Fireman's schedule ".
  • Weekends are included; holidays included as the needs of the business warrant.

Project Description:
  • Provide Quality assistance and oversight to operations, for in-process intermediates and manufactured products, and other GMP processes as required.
  • Performs review and approval of documentation associated with in-process materials, and manufactured product.
  • Assists in the identification, generation and quality review of investigation records that may result during day-to-day operations.
  • Assure the quality of manufactured products complies with all applicable regulations and guidelines.
  • Performs routine manufacturing batch production record review in support of product release in accordance with specifications and SOPs.
  • Assist Operations by providing quality oversight and guidance for atypical events, assessing complex biologics manufacturing issues for forward processing.
  • Perform walkthroughs of GMP areas documenting observations and areas of concern to support audit readiness of the manufacturing facility and support areas.
  • Supports return to service walkthroughs and Manufacturing audit readiness walkthroughs per procedure as needed.
  • Assures all electronic and paper documentation, which requires QA review is in compliance with corporate and site procedures, cGMP regulations, and other industry guidelines.
  • Reviews, approves, and provides guidance for quality master data.
  • Authors and revises Quality specific SOPs and may provide Quality review and approval of manufacturing related SOPs.
  • Monitors and trends batch record errors, batch record review cycle time to support disposition, and walkthrough observations to provide Quality Assurance management with quality indicator data.
  • May support the Quality approval of Master Batch Records.
  • Supports the Quality review and closure manufacturing deviations.
  • Other duties as assigned.

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Maureen: maureen@alphaconsulting.Com


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Maureen O

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