Biomanufacturing Quality Assurance Floor Support

Job Title: Biomanufacturing Quality Assurance Floor Support Location: Devens, MASchedule: : 5AM - 5PM, 12 hour shift. Schedule is like a Panama Schedule (2 days on, 2 days off, 3 days, 2 days off, 2 days on, 3 days off) Weekends are included. Holidays included as the needs of the business warrant. Type: Contract Overview Our client is a leading global pharmaceutical company in Devens, MA. Responsibilities

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 procedures 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.

Requirements

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 is desirable

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.