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QC Stability Specialist

Woburn, MA 01801

Posted: 07/10/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 610502 Is job remote?: No Country: United States

Job Description

Target PR Range: 40-50/hr
*Depending on experience

JOB DESCRIPTION The stability program covers all product stages (Cell Bank, Viral Bank, Plasmid, Drug Substance and Drug Product) at both clinical and commercial development stages to support shelf life and meet global regulatory expectations.  The QC Stability Specialist responsibilities include processing stability samples, collation of internal and external stability assay results, maintaining data trackers, entering stability data in LIMS, assisting with stability protocols and reports. This role will report to the Director of Stability, Quality Control Operations.  

Key Responsibilities: Stability Testing: Perform stability testing on pharmaceutical products according to established protocols, including sample preparation, testing, and data analysis. Conduct stability testing for raw materials, in-process samples, and finished products. Sample Management: Manage the storage and tracking of stability samples in compliance with established procedures. Maintain accurate and detailed records of sample storage conditions and testing schedules. Data Analysis: Analyze and interpret stability data, ensuring compliance with established stability specifications and regulatory requirements. Document and report any deviations or out-of-specification results. Stability Protocols and Reports: Assist in the development and revision of stability study protocols, ensuring that they are scientifically sound and compliant with regulatory guidelines. Prepare stability study reports for submission to regulatory authorities. Instrumentation and Equipment: Operate and maintain analytical instruments and stability chambers used for testing. Perform routine calibration and maintenance activities. Quality Compliance: Ensure adherence to cGMP (current Good Manufacturing Practices) and regulatory guidelines during all stability testing and laboratory operations. Support investigations and CAPA (Corrective and Preventive Action) processes as needed. Inventory Management: Maintain an organized inventory of stability testing materials, reagents, and standards. Assist in procurement and restocking as necessary. Safety and Compliance: Adhere to safety protocols and maintain a safe and clean laboratory environment. Participate in laboratory audits and inspections. Continuous Improvement: Identify opportunities for process improvements and efficiency gains in stability testing and laboratory operations. Actively contribute to quality improvement initiatives. Qualifications: Bachelor's degree in a relevant scientific field, such as Chemistry, Pharmaceutical Sciences, or Biochemistry. Minimum of [X years] of experience in a pharmaceutical quality control or analytical laboratory setting with a focus on stability testing. Strong knowledge of cGMP and regulatory requirements. Proficiency in analytical techniques and instrumentation (HPLC, GC, UV-Vis, etc.). Detail-oriented with excellent analytical and problem-solving skills. Effective communication and documentation skills.
Responsibilities
  • Assist with stability protocols and reports.
  • Utilize LIMS to set up stability studies and organize data.
  • Execute stability studies and conduct schedule pulls.
  • Maintain data trackers for stability studies.
  • Ensures all work performed strictly adheres to UGT SOPS and cGMP requirements.
  • Follows good documentation practices, all safety rules, and regulations.

Requirements
  • Associate or bachelor’s degree in a scientific discipline 
  • 0-2 years of related work experience
  • Ability to work in a fast-paced work environment.
  • Strong attention to detail and organizational skills
  • Ability to drive, and work well, in teams and independently.
  • Functional knowledge of working in a GMP environment
  • Knowledge of LIMS systems, preferred.
  • Knowledge of Stability Studies, preferred.
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About Woburn, MA

Ready to embark on a new career adventure? Explore our job opportunities in the vibrant area around Woburn, Massachusetts! Nestled in Middlesex County, 'Woburn, the Beautiful Land' as it translates, offers job seekers a mix of urban excitement and suburban charm. With close proximity to Boston’s bustling city life and historical landmarks like the Minute Man National Historical Park, as well as delightful local cuisines including Woburn's signature roast beef sandwiches, this area promises not just a job but a lifestyle. Attend performances at The New Repertory Theatre or catch a game at the TD Garden supporting the region's beloved sports teams. Take a stroll in Horn Pond Recreation Area or immerse yourself in art at the Whistler House Museum of Art in nearby Lowell. Join us in pursuing your career in this dynamic region; your next big opportunity awaits!

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