Sr QA Specialist

Agawam, Massachusetts, United States Full-time

Position Title: Sr. Quality Assurance Specialist
Job Location(s): Agawam, MA
Start Date: ASAP
Employment Type: Full Time
Starting Salary Range: Competitive
Job Requisition #: 18036

Avista Pharma Solutions is a contract testing, development and manufacturing organization (CDMO) encompassing over 200,000 square feet of laboratory and manufacturing space across the U.S. and U.K. (Agawam, MA – Durham, NC – Longmont, CO – Edinburgh, Scotland), providing pharmaceutical, animal health and medical device clients with a broad suite of scientifically-differentiated services.

DUTIES:

  • Sr QA Specialist II will be required to:

o   Oversee all Quality System Management Review planning and review process.

o   Oversee, coordinate and review tracking of Deviations, Change Controls, CAPAs and OOS events for the site.

o   Lead and/or participate in Root Cause Analysis (RCA) sessions as needed

o   Review and approval of laboratory test records, deviations, change controls, corrective and preventive actions (CAPA) and specifications. 

o   Prepare, maintain and analyze metrics related to the quality systems.

o   Support the quality team to achieve quality goals and metrics.

o   Coordinate and support Internal, Supplier and Client audits.

o   Leading project improvement projects as needed and assigned.

  • Additionally, Sr. Quality Assurance Specialist II will be responsible for:

o   Quality review of analytical and stability data.

o   Review and release of Analytical, Microbiological and Environmental Monitoring reports utilizing our Laboratory Information Management Systems (LIMs).

o   Review and approve documents in the document management system.

o   Communicate effectively with internal personnel, as well as external customers (if applicable).

 

QUALIFICATIONS:

  • BS or BA Degree with 8+ years, MS Degree with 3+ years, or PhD with 0-2+ years of experience working in a Biotech or Pharmaceutical FDA regulated industry.
  • Experience leading CAPA and Deviation Management to closure.
  • Prior experience conducting internal and supplier audits.
  • Prior experience maintaining pharmaceutical quality systems.
  • Experience with and working knowledge of cGMP and GLP quality systems, policies and regulations/guidelines.

SUCCESS FACTORS:

  • Ability to lead and coordinator cross-functional projects.
  • Ability to influence others for the better of the company.
  • 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.
  • Ability to influence employees in a matrix organization to ensure completion to pre-established due dates.
  • Excellent diplomatic, analytical, and communication skills – both verbal and written.

Avista Pharma Solutions 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.