Randstad Quality Control Specialist in North Billerica, Massachusetts
Quality Control Specialist
location:North Billerica, MA
salary:$70,000 - $102,000 per year
date posted:Sunday, February 24, 2019
industry:Professional, Scientific, and Technical Services
Quality Control Specialist
Senior Quality Systems Specialist
The Senior Quality Systems Specialist is responsible for managing the Annual Product Quality Reports (APQR), Customer Quality Complaints, Investigations, Corrective Actions, First Pass Quality and Metrics Reporting. Other functional responsibilities include authoring and revising Quality System Documentation, trending and evaluating Product Quality and performing Internal Audits of the quality management system.
location: North Billerica, Massachusetts
job type: Permanent
salary: $70,000 - 102,000 per year
work hours: 8 to 4
Key Responsibilities/Essential Functions
Manages Annual Product Quality Reports (APQR) collaborating with internal stakeholders.
Evaluates scientific data for trends, drives Investigations and determines the need for changes in drug product specifications, manufacturing or control procedures.
Performs Product Quality Complaint Investigations and drives closure of associated CAPA(s).
Collaborates with Technical Support, Engineering, Analytical Laboratories, Manufacturing, Validation, Customer Service and Regulatory Affairs groups to ensure timely complaint investigations and closure.
Facilitates third-party supplier and CMO investigations and requests for corrective actions.
Performs routine trending of product complaints and evaluating trends, escalating issues as necessary.
Additional tasks include: performing internal audits, providing support during external audits, reviewing documents for compliance with regulatory guidelines and applicable standard operating procedures, authoring document changes, managing change controls, and supporting quality metrics initiatives.
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 & environmental hazards.
Actively demonstrates the Client values of accountability, quality, customer service, efficiency, collaboration and safety.
Bachelor of Science in a technical discipline or equivalent combination of education and experience.
Minimum of 5 years of experience in quality and manufacturing in the pharmaceutical, medical device, or biological industries.
Experienced in Annual Product Quality Reviews, managing Customer Product Quality Complaints, effectively communicating in written form and collaborating with various internal and external business partners in problem resolution
skills: SOP, Quality Assurance, CAPA, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.