Specialist, External Quality Assurance, Batch Disp

Specialist, External Quality Assurance, Batch Disp
  • $35 - $45 per Hour
    HOUR
  • Temporary
  • Norwood MA, US Norwood NORFOLK US 02062
Job Ref: JO000122353
Sector: Science
Sub-sector: Food & FMCG
Date Added: 01 September 2021



Specialist, External Quality Assurance, Batch Disposition - 1st shift

6 month renewable contract

Our client is seeking a (Contract) Specialist of Quality Assurance Batch Disposition reporting to the Manager of External Quality Assurance, Batch Disposition. The individual in this role will be responsible for providing Quality support in batch disposition related to external aseptic fill/finish activities. The individual will work with contract manufacturing and internal functions to ensure robust processes and systems are implemented in support of the clients CMC development programs in conjunction with commercial filling milestones. This individual will execute based upon implemented quality systems / standards. The successful candidate must have experience in a biotech or pharmaceutical development environment and knowledge of cGMP quality systems. This position will be 1st shift from 7:00 am to 3:00 pm working Sunday through Thursday.
Here's What You’ll Do:
Perform all activities required for commercial and clinical batch disposition
Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met
Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met
Support Manager to collect and report targeted metrics for Management Review
Support Quality Agreement review with contract manufacturers
Review protocols, analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans
Collaborate with Manufacturing and lead investigation teams to resolve equipment and process related deviations
Conduct internal audits, track progress, and trend results
Provide guidance on GMP manufacturing from Phase I to Commercial
Support Annual Product Review report generation and approval as needed
Write, review and approve GMP documentation (SOPs, protocols, technical reports, technology transfer protocols, specifications, summary reports to support GMP production, change controls, etc.) as needed
Here’s What You’ll Bring to the Table:
BS with at least 4 years of experience, or a Master’s level degree and 2 years’ experience in the pharmaceutical/biotech industry
Working knowledge of relevant FDA, EU, ICH guidelines and regulations.
Experience working with CMOs, vendors, and relationship management preferred.
Experience working with aseptic fill and finish of vials preferred.
Familiarity with PDA Technical Reports 22, 26, 60, and 79 preferred.
Knowledge of late-stage pharmaceutical development and validation principles preferred
Excellent judgment and ability to communicate complex issues in an understandable way.
Outstanding communication skills (verbal and written).
Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
Travel up to 10%.

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

SRGTalent
30/09/2021 12:00:00
USD 35.00 45.00 Hour
Contact Consultant:
Jennifer Law

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