Quality Control Specialist

2 weeks ago

Millburn, United States Medasource Full time

Quality Control Specialist

Client: Large Healthcare Company

Location: Millburn, New Jersey

Duration: 7-month contract (possible extensions)

Benefits: Health, Dental, & Vision


Project Goal & Overview:

Novartis is committed to providing high-quality, safe, and effective medications to improve patient outcomes worldwide. They are looking for a Quality Control (QC) Specialist to support site technical development of quality control methods/processes, method and instrument validations, and technical transfers associated with Analytical and/or Microbiological quality control testing of product, raw materials, and packaging components. This individual will play a vital role in maintaining compliance with regulatory requirements and contributing to the continuous improvement of quality control processes. We are looking for this person to be a strategic thinker, great team player, and a true problem solver.


Deliverables/Milestones:

· Develops QC method and instrument qualifications, as well as technical transfer protocols from third party laboratories or other Novartis sites.

· Executes testing for method and instrument implementation, as well as qualification/validation protocols, as needed.

· Supports deviation investigations and OOS/OOT/OOE investigations, if needed.

· Provides technical insight in case of QC testing non-conformances and deviations.

· Responsible for successful on time completion of required training curricula comprising of the necessary Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications, Testing and specifications, and other relevant training including HSE for the specific role.

· Prepares applicable documents, forms, and records, such as method or instrument qualification/validation records, and follows Good Documentation Practices.

· Supports internal and external Audits and Inspections, if needed.


Qualifications:

· Bachelor of Science degree in Chemistry, Biology, Engineering, or related field required.

· 1-3 years of experience working in quality control in the pharmaceutical industry, specifically within a GMP-regulated environment.

· Strong knowledge of analytical techniques and instruments.

· Strong knowledge and experience of Quality Control testing and methodologies.

· Familiarity with FDA regulations and ICH guidelines.

· Excellent attention to detail and ability to follow standard operating procedures (SOPs) and protocols.

· Demonstrated problem-solving skills and ability to troubleshoot analytical methods and instrumentation.

· Effective communication skills, both written and verbal, with the ability to work collaboratively in a team environment

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