Stability Program Specialist

2 weeks ago

Woodstock, Illinois, United States Woodstock Sterile Solutions Full time
Job Overview

Woodstock Sterile Solutions is committed to enhancing global healthcare by delivering top-tier solutions for sterile development and commercial requirements. As a dynamic organization, we are seeking skilled and driven professionals to join our expanding team. We provide a comprehensive benefits package along with a generous Paid Time Off policy.

I. Role Summary:

The Stability Coordinator is tasked with managing the stability program within the Quality Control chemistry laboratory. This role encompasses the initiation of stability protocols, coordination of stability sample pulls in collaboration with external laboratories, ensuring prompt testing of products, conducting stability assessments, compiling stability reports, and analyzing stability data as necessary. The individual will work closely with various departments, external laboratories, and clients, upholding a strong commitment to Safety, Quality, and Compliance.

II. Key Responsibilities:

  • Familiarity with cGMPs, USP, and FDA regulations (21 CFR Parts 210 and 211) relevant to stability program management.
  • Engage with clients, customer service representatives, and project managers to determine product lots, sample sizes, stability study plans, testing needs, acceptance criteria, and the types of stability studies required.
  • Identify contract laboratories for tests that cannot be conducted in-house and assist with obtaining quotes.
  • Draft stability protocols prior to the commencement of stability studies and review protocols from contract labs as needed.
  • Collaborate with clients and other departments to establish stability specifications within the quality system of Woodstock Sterile Solutions.
  • Create and oversee monthly stability pull lists.
  • Document the receipt of stability samples in the appropriate logbook.
  • Ensure timely testing of stability samples and perform testing as required.
  • Proficient in the use of analytical laboratory instruments (e.g., Analytical Balance, pH meter, Conductivity Meter, Densitometer, Auto-titrator, Viscometer, Osmometer, UV-Vis, HPLC/UPLC).
  • Review stability data to confirm that testing and documentation comply with internal procedures and stability protocols.
  • Promptly identify and report any Out of Specification (OOS), Out of Trend (OOTr), or atypical data to chemistry management and Quality Assurance Product Managers (QAPMs), assisting with laboratory investigations related to stability studies.
  • Compile analytical data into stability reports and trend the data over the product's shelf-life as necessary, supporting annual stability reports.
  • Ensure all stability activities comply with current Good Manufacturing Practices (cGMP) and other regulatory standards.
  • Assist with additional stability requests beyond the annual stability requirements as needed.
  • Maintain current training on relevant equipment and procedures.
  • Keep thorough records and documentation, adhering to current Good Documentation Practices (cGDP).
  • Communicate effectively with team members and stakeholders to facilitate smooth project execution.
  • Support other testing activities, including in-process, finished product, rinse, and WFI samples when time allows or as necessary to meet production or client timelines.
  • Identify, assess, and manage risks to ensure product quality, communicating risk policies and processes throughout the organization.
  • Maintain the effectiveness of the Quality System components pertinent to this role.
  • Perform other duties as assigned.

III. Qualifications:

Education:

  • Bachelor's degree in pharmaceutical science, chemistry, or a related field, or equivalent work experience.

Experience:

  • 1-3 years of experience in a pharmaceutical cGMP laboratory.

Knowledge/Skills:

  • Proficient in data analysis software and Microsoft Office.
  • Strong organizational and time management skills with exceptional attention to detail.
  • Excellent documentation abilities.
  • Knowledge and experience in a cGMP environment.
  • Effective communication and teamwork skills.
  • Ability to work independently and manage multiple tasks simultaneously.
  • Demonstrated proficiency in reading, writing, and speaking clear English.
  • Experience in managing a stability program is preferred but not required.

Physical Requirements:

  • Ability to stand for up to 8 hours per day.
  • Visual Acuity (20/30 corrected vision).
  • Frequent sitting, standing, walking, reading of written documents, and use of computer monitor screen, reaching with hands and arms, writing, talking, and listening.
  • Occasional stooping, kneeling, crouching, bending, handling, carrying, and grasping.
  • Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 30 pounds.

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