Sr QA Specialist - Audits

Durham, North Carolina, United States Full-time

 Position Title: Senior Quality Assurance Specialist 1
Job Location(s): Durham, NC
Start Date: ASAP
Employment Type: Full Time
Starting Salary Range: Competitive
Job Requisition #: 18077

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 will be required to:
    • Support the quality team to achieve quality goals.
    • Assist the quality team daily to accomplish efficient and effective review / audit of daily reports as assigned including, but not limited to: certificates, procedures, protocols, reports, and non-conforming event reports.
    • Communicate effectively with internal personnel, as well as external customers (if applicable).
  • Additionally, Quality Assurance Specialist will be responsible for:
    • Document Archive Management: organize inventory records in a manner that provides efficient and effective viewing and retrieval including but not limited to: testing records, training records, and equipment records.
    • Auditing: support internal audits, client audits, and regulatory audits including, but not limited to: document retrieval, room setup, document clean up.
    • Metrics: prepare, maintain and analyze metrics related to the quality systems.
    • Supplier Management: review, evaluate and maintain supplier, vendor and contractor qualifications

 

QUALIFICATIONS:

  • BS or BA Degree with 6 - 8+ years, MS Degree with 2+ years, or equivalent
  • Experience with GMP and GLP quality systems and policies.
  • Knowledge of requirements in the pharmaceutical industry.
  • Knowledge of equipment and software validation and qualifications
  • Mathematical skills including the ability to analyze scientific and test data and a basic understanding of statistical analysis.

 

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.