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Senior QA Specialist – QA Validation/Quality Engineering (cGMP – Pharmaceutical)

JD820662

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.:
4+
Date Posted:
15/04/2020
Days Remaining:
32
Employment Type:
Full-time
Education Level Req.:
Bachelors

Senior QA Specialist – QA Validation/Quality Engineering  (cGMP – Pharmaceutical)        JD820662

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:

  • Perform reviews of Validation Lifecycle documents including, but not limited to, Functional, Detailed Design, Configuration and User Requirement Specifications (FS/DDS/CS/URS) and Factory and Site Acceptance Test (FAT/SAT) protocols and Reports from a quality perspective to ensure compliance to internal requirements.
  • Perform reviews of protocols and reports relating to Facilities, Utilities, and Equipment commissioning and qualification/requalification, process/method validation, and other cGMP activities from a quality perspective to ensure compliance to internal requirements and sound technical rational.
  • Review and approve deviations and CAPAs; including performing Failure Mode Effect Analyses (risk assessments), participating in root cause analysis investigations, evaluating CAPA effectiveness, and oversight of departmental training.
  • Review and approve change controls with a focus on those pertaining to equipment, facilities, utilities and process changes ensuring validation impact, procedural impact, regulatory impact, and prescribed testing is adequate and well justified.
  • 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.
  • Represent Quality Assurance on project teams and in meetings.
  • Support the continuous improvement and oversight of Quality Management System procedures.
  • Provide any additional QA support as necessary (e.g. Review and approve batch records).

 

Qualifications:

  • Bachelors of Science degree in Engineering, Chemistry, Biology or related field.
  • 4+ 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.
  • Capable of working with minimal supervision and ability to work well with diverse groups.
  • Good verbal and written communication skills.
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