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Quality Assurance Specialist II

Location

Agawam, MA, USA

Department

Quality Assurance

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Position Title: Quality Assurance Specialist II
Job Location(s): Agawam, MA
Start Date: ASAP
Employment Type: Full Time
Starting Salary Range: Competitive
Job Requisition #: 18101

Cambrex (www.Cambrex.com) is seeking a highly motivated, energetic, results-oriented individual to join our team of dedicated professionals focused on customer service and quality. We are currently accepting resumes.

DUTIES:

  • QA Specialist II will be required to:
    • Support the quality team to achieve quality goals.
    • Assist the quality team daily to accomplish efficient and effective review and approval of records as assigned including, but not limited to: calibration and maintenance work, procedures, validation protocols, validation reports, deviations and change controls.
    • Communicate effectively with internal personnel, as well as external customers (if applicable).
  • Additionally, Quality Assurance Specialist II will be responsible for:
    • Quality review of analytical/microbiological testing data
    • Auditing: support internal audits.
    • Metrics: prepare, maintain and analyze metrics related to the quality systems. 

QUALIFICATIONS:

  • BS or BA Degree with 3+ years, MS Degree with 1+ years
  • Experience with GMP and GLP quality systems and policies.
  • Knowledge of requirements in the pharmaceutical industry.
  • Previous experience with electronic data bases, MasterControl, TrackWise, LIMS preferred

SUCCESS FACTORS:

  • Participate in developing department goals, objectives, and systems.
  • Exceptional analytical and problem-solving skills with the proven ability to think strategically.
  • Highly effective team and interpersonal skills with the ability to work across numerous scientific and management disciplines.
  • Excellent diplomatic, analytical, and communication skills – both verbal and written.

Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.