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Quality Assurance Specialist - Boston MA - 15566

Boston, MA

Posted: 06/29/2022 Industry: Scientific and Life Sciences Job Number: 14564

Job Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.

Title: Quality Assurance Specialist, Quality Engineering

Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

  • Duration: Temp-to-perm
  • Pay rate: $ 60-$70/hr
  • Job Location: Boston
  • Job#: bh14564

Quality Assurance Specialist, Quality Engineering

KEY RESPONSIBILITIES:

  • Primarily responsible with supporting quality oversight to VMC operations in the following key areas/activities; engineering, validation/qualification, facilities and utilities support.

 

Compliance Oversight of Internal Operations – QA Engineering

  • Review and approval of calibrations, PMs, eCRs, work orders and laboratory operations via instrument qualifications
  • Review and approval of change controls, qualification activities, and periodic assessments.
  • Review and approval of trending programs (equipment, facility, utilities, etc.)
  • Support EM and UM programs and control programs (Veriteq, pest control)
  • Provide support of facilities and engineering projects, including capital projects, annual plant shutdown, and various improvement projects as assigned.
  • May assist the QA Operations group activities such as area or line clearance.

Compliance Oversight of Quality Systems

  • Provide QA support of Equipment and Facility change controls, GMP investigations, associated CAPAs and Effectiveness Checks. Support collaboration with customers to ensure quality systems are monitored and established metrics are met.
  • Support monitoring and tracking performance metrics, trends; including site metrics for investigation/CAPA, Equipment and Facility Change Controls, etc.
  • Support biennial review and approval of department and cross-departmental processes for continuous improvement.
  • Support compliance walkthroughs of the site and help drive the closure of any observations.
  • Ability to identify risks and communicating gaps for GMP process/systems.

 

Audit / Inspection Support

  • Support inspection readiness activities and provide support during regulatory site inspections. Provide post inspection support to address any regulatory observations.

 

Individual Development and Training

  • Responsible for timely completion of trainings (100%), goal development, self-evaluation and IDP

 

REQUIRED EDUCATION AND EXPERIENCE:

  • Demonstrated success independently leading cross-functional teams
  • Experience providing QA support and oversight of GMP manufacturing operation
  • Experience with drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge of the following in a pharmaceutical setting:
    • cGMP’s and associated CMC regulatory considerations
    • experience with continuous manufacturing a plus
  • Experience with equipment, facilities and utility system qualifications activities in a cGMP setting, including change controls
  • Experience with event investigations, Root Cause Analysis (RCA), and CAPA
  • Experience with Oracle and Veeva Quality Systems preferred.
  • B.S in scientific or allied health field (or equivalent degree) and 3+years of relevant work experience


 

 

Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.

 

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Meet Your Recruiter

Alexandra (Scuncio) Pettit
Team Lead, Sr. Technical Recruiter

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