Senior Quality Control Associate

Proclinical is partnering with an innovative biotechnology company to advertise a new vacancy for a Senior Quality Control Associate position. This organisation, which specialises in RNAi therapeutics, is seeking for an exceptional individual to join their team in Massachusetts on a contract basis.

Job Responsibilities:

• Completing material specification processes related to the onboarding of new raw materials, or revising existing raw materials, in support of our new manufacturing facility.
• Working collaboratively with the raw material vendors, internal quality control, process and analytical sciences, manufacturing, and quality assurance departments; ensuring that the raw material specification packages meet and that regulatory expectations, such as Change Control and Vendor assessment, are implemented in a timely manner.
• 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 are complete and meet company & regulatory requirements.
• Generating and/or revising necessary documentation for new and existing raw materials.

Skills and Requirements:

• A BSc degree, or equivalent, in a related field.
• At least 10 years of GMP QC laboratory or biotech/pharmaceutical industry experience.
• Expertise in the raw materials program, including a clear understanding of various regulatory requirements.
• Experience with direct involvement in material specification setting and justification is preferred.
• Demonstrable experience in technical oversight of QC raw material sampling, testing, and specification.
• An understanding of USP, Ph EUR, and JP compendial requirements.
• Prior experience in GMP and Regulatory settings a desirable bonus.
• A thorough understanding of GMP and Regulatory guidelines.
• A thorough knowledge of statistical methods and computer skills.
• Knowledge of Oligonucleotides-related raw materials a beneficial, but non-essential, attribute.
• Capable of travelling between domestic sites.
• Excellent interpersonal skills, including communication, persuasion, and negotiation.
• Excellent organisational and prioritisation skills with a great attention to detail.
• Proficiency with Microsoft Office.
• Excellent English oral and written skills.
• Strong team ethos, with a demonstrated track record of success in cross-functional teams and a fast-moving environment.

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 call Corrin Pyle on + 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.

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