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Senior QA Specialist – Manufacturing Support (cGMP – Pharmaceutical) JD820661

JD820661

DPS is looking for a Senior Quality resource to work with a pharmaceutical client in the Cambridge/Lexington, MA area. Ideal candidates should have a strong understanding of GMP and have previous experience working within highly regulated pharmaceutical/biotech facilities. This individual will support day-to-day quality operations via oversight of all elements of the Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), investigations, excursions, Out of Specifications (OOS), change control, batch review and disposition, data integrity, and training in support of biologics manufacturing production.

Category:
Quality
Location:
Massachusetts
Years of Experience Req.:
6+
Date Posted:
15/04/2020
Days Remaining:
32
Employment Type:
Full-time
Education Level Req.:
Bachelors

Senior QA Specialist – Manufacturing Support  (cGMP – Pharmaceutical)        JD820661

Boston, MA area

 

DPS is looking for a Senior Quality resource to work with a pharmaceutical client in the Cambridge/Lexington, MA area. Ideal candidates should have a strong understanding of GMP and have previous experience working within highly regulated pharmaceutical/biotech facilities.

 

This individual will support day-to-day quality operations via oversight of all elements of the Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), investigations, excursions, Out of Specifications (OOS), change control, batch review and disposition, data integrity, and training in support of biologics manufacturing production.

 

Responsibilities:

  • Support cGMP manufacturing and laboratory operations through administration and enforcement of the Quality Management System including, but not limited to, deviations, change controls, and CAPAs.
  • Review and approve batch records.
  • Perform the review and approval of commissioning and qualification documentation for facilities, equipment, and utilities.
  • Review and approve preventative maintenance, calibration, and work order documentation.
  • Support internal and external audits.
  • Support the supplier quality program through review and approval of vendor change notifications, part number requests, raw material specifications, and raw material release.
  • Review, assist in the investigation of, and approve environmental excursions.
  • Provide on-the-floor QA support for manufacturing activities.
  • Represent Quality Assurance on project teams and in meetings.
  • Support the continuous improvement and oversight of Quality Management System procedures.

 

Qualifications:

  • Bachelors of Science degree in Engineering, Chemistry, Biology or related field.
  • 6+ years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment.
  • Well versed in cGMP/ICH/FDA/EU regulations and guidelines.
  • Proficient in using Microsoft applications.
  • Capable of working with minimal supervision and ability to work well with diverse groups.
  • Good verbal and written communication skills.
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