Devens,
MA
01434
US
Posted: 07/25/2023
2023-07-25
2023-10-31
Job Number: 24549065
Job Description
BIOMANUFACTURING QA FLOOR SUPPORT
DEVENS, MA
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
ALPHA'S REQUIREMENT #23-01286
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
#LI-DNI
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