Quality Control Specialist

Highly Competitive
  1. Permanent
  2. Good Clinical Practice (GCP)
Boston, Massachusetts
Posting date: 26 Feb 2019

ProClinical is partnering with a leading biotechnology company to advertise a vacancy for a Quality Control Specialist position. This organisation, which develops highly selective and potent kinase therapies, is seeking an applicant to join their team in Massachusetts. This is an exciting opportunity for an individual with expertise in Quality Control.

Job Responsibilities:

  • Representing Quality Control in a highly matrixed, cross-functional environment.
  • Supporting the establishment of Quality Control systems to support commercialization activities.
  • Supporting commercial readiness activities at external laboratories.
  • Supporting the company's stability program(s) through tracking of stability pulls, internal data summaries, and preparing data for statistical analysis.
  • Supporting activities to streamline data reviews, stability data reporting, stability protocols, and reports across external labs.
  • Pro-actively seeking out updates from external laboratories and ensuring that internal records are maintained for stability.
  • Helping to establish on time performance metrics for stability report preparation and tracking on time stability testing.
  • Reviewing data for CTM batch release, including API and drug product data review.
  • Working with internal stakeholders, including QA and Technical Operations, to ensure the timely sharing of information and seeking out input from these stakeholders as required.
  • Providing support for OOS/OOT investigations, as required.

Skills and Requirements:

  • A BS Degree in Chemistry, Biochemistry, Biology, or a related discipline with 5 years of relevant industry experience.
  • Demonstrable experience in a GMP laboratory, including QC drug substance and drug product stability, preferably in small molecule experience.
  • Experience in preparing stability protocols and reports, including the statistical analysis of data.
  • Experience in OOS/OOT resolution, root cause analysis tools, and monitoring the effectiveness of CAPAs.
  • A good working knowledge of ICH stability guidelines.
  • Experience with analytical testing techniques, including HPLC, GC, KF, and dissolution.
  • 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 Mary Jacobs at +44 267-477-4800 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.