- Petersburg, VA, United States
Kelaca is looking for a Stability Associate for our client partner in Petersburg, VA. The role is essential to assure the Petersburg site’s manufacturing and operations activities comply with applicable regulatory standards (e.g., Current Good Manufacturing Practices, Good Distribution Practices) and expectations for the development and reliable supply of quality medicines.
Responsibilities of the position include working cross-functionally to establish and maintain the stability program for the Petersburg site.
Responsibilities of the position include but are not limited to working cross-functionally to establish and maintain the stability program at the Petersburg site. As well as the generation, review and/or approval of policies, procedures, reports, protocols, investigation, change controls and other records necessary for the stability program to ensure FDA requirements are met.
- Work across functions to support the development and maintenance of the stability program at the Petersburg site.
- Author stability protocols for new drug products and annual commitment batches, as per current procedures and regulatory requirement.
- Support the shipment of samples to the appropriate external testing facilities.
- Work directly with Contract laboratories to coordinate and monitor testing schedules.
- Track sample receipt, testing and obtain results and raw data from contract labs.
- Build and manage stability data in the LIMS system.
- Supports Annual Product Reviews and Annual Reports for existing products and provides relevant stability reports as needed.
- Support overall sample management and Quality Control Operations as needed.
- Compile stability metrics, trend data and report to Management.
- Ensure that all aspects of the handling, and manufacturing of pharmaceutical products at the site comply with Company and relevant FDA and Drug Enforcement Administration (DEA) regulatory requirements.
- Practice and promote a safety and quality mindset and a quality excellence approach to all activities.
- Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
Skills and Experience:
- Bachelor’s degree in a scientific discipline with a minimum of 5 years Quality/CGMP experience in the pharmaceutical industry.
- Experience in managing stability studies.
- Excellent written/oral communication skills with a strong discipline in Microsoft Programs is required.
- Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
- Ability to work autonomously within established guidelines, procedures, and practices.
- Committed to delivering high quality results, overcoming challenges, and focusing on what matters.
- Continuously looking for opportunities to learn, build skills and share learning.
- Experience with Laboratory Information Management Systems (LIMS).
- Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances is desired.
Job Type: Full-time
Hours of Work in Office: Monday-Friday; 7am-4pm
FLSA Exemption Status: Non-Exempt
Apply to Kelaca today so we can schedule a conversation with you to further discuss this exciting opportunity.
Thursday, May 11, 2023