Quality Control Manager

Highly Competitive
  1. Permanent
  2. Pharmacology
  3. United States
Cambridge, Massachusetts
Posting date: 05 Mar 2019

ProClinical is advertising a vacancy for a Quality Control Manager position with a revolutionary biotechnology company that translates RNAi into a new class of medicines. RNAi therapeutics are focused on genetically defined targets and are used to treat serious, life-threatening diseases with limited treatment options for patients and their caregivers. The Quality Control Manager will join this innovative company in their team in Massachusetts.

The Quality Control Manager will join the company's Quality Control team and will be responsible for driving completion of the materials specification processes related to the onboarding of new or revised existing raw materials in support of the company's new manufacturing facility.

Job Responsibilities:

  • Working collaboratively with the raw material vendors, internal quality control, process, and analytical sciences, manufacturing, and quality assurance departments to ensure that the raw material specification packages meet regulatory expectations. This includes, but is not limited to, Change Control, Raw Material Request Forms, Vendor assessment, Risk Assessment, Classification, Specification Documents.
  • Ensuring that Justification of Specifications, Materials Receipt, Sampling, and Release requirements are in place in a timely manner.
  • Assisting with devising and establishing the raw material specifications for the Manufacturing Facility in collaboration with Process and Analytical Sciences, Manufacturing, QA, and QC SMEs.
  • Coordinating activities to ensure all specification-related documentation is complete and meets regulatory requirements.
  • Generating and/or revising necessary documentation (e.g., raw material request form, change controls, risk assessment, material number request, risk assessments, classification, and specifications and their justifications, etc.) for new and existing raw materials.

Skills and Requirements:

  • A BS degree or equivalent.
  • At least ten years of GMP QC laboratory or biotech/pharmaceutical industry experience.
  • Expertise in the raw materials program, including a clear understanding of various regulatory requirements.
  • Prior experience in technical oversight of QC raw material sampling, testing, and specification is required.
  • Direct involvement in material specification setting and justification is preferred
  • Understanding of USP, Ph EUR, and JP compendial requirements
  • Prior experience in GMP and Regulatory settings a plus
  • Excellent interpersonal and communication (verbal and writing) skills
  • Good understanding of GMP and Regulatory guidelines
  • Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solve problems.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency in MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Corrin Pyle at +267-435-8555 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.