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Quality Systems Specialist, Complaints

2 months ago

North Billerica, United States Randstad Life Sciences Full time
Job DescriptionJob Description

Immediate opportunity for Quality Systems Specialist, Compliants with a leading pharmaceutical/diagnostics company located in North Billerica, MA.  As a Quality Systems Complaints Specialist, you will be responsible for investigating Product Quality Complaints.  Other responsibilities may include authoring and revising Quality System Documentation, trending and evaluating Product Quality, and coordinating the Annual Product Quality Reports (APQR), and Metrics Reporting.

Schedule Shift: 1st shift, Mon.-Fri.; Onsite 4-5 days in Billerica until trained, then 3 days onsite. Can do a short week for summer hours.

Position Type: Contract role for 6 mos. (through Jan 2025); extension possible

Pay Rate: $50+/hr.

Essential Duties and Responsibilities:

  • Initiates product quality complaints in our Quality Management System (QMS).
  • Performs product quality complaint investigations and assigns investigation tasks to technical functions as needed.
  • Collaborates with Technical Support, Engineering, Analytical Laboratories, Manufacturing, Validation, Customer Service and Regulatory Affairs groups to ensure timely complaint investigations and closure.
  • Evaluates scientific data for trends, drives investigations, and proposes the need for changes to manufacturing or control procedures.
  • Documents complaint investigation activities and summary. Responsible for timely closure of complaints.
  • Recommends the need for further investigation and escalation to CAPA. Drives closure of associated investigation(s) and CAPA(s).
  • Performs routine trending of product complaints and evaluating trends, escalating issues as necessary.
  • Responsible for Annual Product Quality Reports (APQR). Collaborates with internal stakeholders on data collection and ensures timely completion of reports.
  • Responsible for collecting and reporting metrics as required per internal procedures and as requested by leadership.
  • Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment.  Reports and takes initiative to correct safety and environmental hazards.
  • Actively demonstrates company values.
  • Other duties as assigned.

Qualifications:

  • Bachelor of Science in a technical discipline or equivalent combination of education and experience.
  • Five (5) or more years' experience in quality and manufacturing in the pharmaceutical, medical device, or biological industries.
  • Experienced in investigating and documenting Customer Product Quality Complaints, effectively communicating in written form, and collaborating with various internal and external business partners in problem resolution.
  • Experienced with metrics reporting.
  • Organized, detail oriented and self-motivated.
  • Exposure to Annual Product Quality Reviews preferred, but not required.
Company DescriptionA great company doing groundbreaking and important work with a great reputation in the industryCompany DescriptionA great company doing groundbreaking and important work with a great reputation in the industry