Randstad USA Disability

Job Information

Randstad Quality Control Specialist in North Billerica, Massachusetts

Quality Control Specialist

job details:

  • location:North Billerica, MA

  • salary:$70,000 - $102,000 per year

  • date posted:Sunday, February 24, 2019

  • experience:5 Years

  • job type:Permanent

  • industry:Professional, Scientific, and Technical Services

  • reference:27910

job description

Quality Control Specialist

job summary:

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

education: Bachelors


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.


Job Requirements

  • 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.