Quality Assurance Supervisor

  • Location
    Marlborough, Massachusetts
  • Job type
  • Category
    Medical & Science - Regulatory

Adecco, a division of the world leader in the recruitment of office and finance professionals is currently recruiting for a QA Compliance Lead, with Marlborough, MA.

***Applicants must be currently authorized to work in the United States on a full-time basis. This employer will not sponsor applicants with the following work visas: H1B, H2B, E3, TN1***

POSITION: QA Compliance Lead
LOCATION: Marlborough, MA
DURATION: 6 months
PAY: $40.70 / hr

- Participating in the development and maintenance of quality systems, processes and procedures to assure product quality and safety.
- assisting the quality assurance site manager in preparation for internal/external audits and implementation of corrective actions to address non-conformities
- supporting risk management process throughout the product life cycle and providing senior mgt with key data from RA to help drive decisions.
- Supporting, development and maintenance of product approval/clearance/licensing documentation and notifications as required by global regulatory agencies

- Assist in ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
- communicates and implements a strategy to ensure compliance
- responsible for review of batch records in support of disposition of bulk drug substance
- responsible for review of equipment validation protocols and report
- general compliance quality systems management support for the following areas:
- Raw material and solution release
- Review of raw material specifications and solution docs
- Release of single use disposable product to include label reconciliation
- review of temp. charts and docs or temp related excursions
- review and update label issuance and reconciliation process

General QA documentation support to include the following:
- Issuance of batch records and issuance and tracking of log books, lab notebooks and SOP binders
- Scanning and filing of excursion docs and client related batch docs to support batch release
- Develops process improvement plans using a variety of quality and continuous process improvement tools, including but not limited to Six Sigma, Lean Manufacturing, SS, SPC, engineering studies, DOE Gauge R&R, etc.

- BA degree or a min. of 5yrs work exp.
- 3 years exp working in a regulated industry
- Demonstrated understanding or aptitude to understand drug or Pharma QMS requirements and regulatory requirements including but not limited to FDA, CFR 21 210 and 211
- Demonstrated exp. and proficiency with MS Office, word processing, spreadsheet(Excel), presentation and database applications.

How to Apply: Click on “Apply Now” to be considered for this position or any other opportunities with Adecco.

IMPORTANT: This position is being recruited for by Adecco’s National Recruitment Center, not your local Adecco Branch Office. To be considered for this position, you must use the “apply now” button to submit your resume. If you have questions about the position, you may contact the recruiter recruiting for this position listed above. For other opportunities available at Adecco go to www.adeccousa.com.

If you have any questions surrounding the application process, please feel free to reach out to: Matthew Greene at matthew.greene@adeccona.com

The Adecco Group is a global leader in HR services. Our group connects over 700,000 associates with our business clients each day through our 6,600 offices in over 70 countries and territories around the world. We offer employment opportunities at any stage in your professional career. Contact us today to discuss available contract and direct hire positions. Adecco Group provides one of the most comprehensive benefits packages in the industry to contract workers to include Holiday, 401(k), Insurance Benefit Plans and Service/Anniversary Bonus opportunities.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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Reference number US_EN_2_022862_399429