MedPharm · 2 days ago
Stability Coordinator
Durham, NC
Full-time
Onsite
Mid, Senior Level
2+ years expMedPharm is focused on managing the Stability program for their QC/R&D laboratories. The Stability Coordinator will oversee the execution of stability protocols, manage stability projects, and collaborate with various departments to ensure product quality and compliance.
BiotechnologyDeveloper PlatformManufacturingPharmaceutical
Responsibilities
Author stability protocols prior to the initiation of the stability study
Collaborate with QC, QA, Program Management, and / or AR&D to identify products, testing criteria and type of stability studies required
Initiate and track stability sample requests per company procedures
Receive and document stability samples into the respective inventory schedules
Create stability pull lists for each month, depending on the type of stability study
Perform timely pulls of stability samples and track timely completion of all stability projects
Perform testing of stability samples as needed
Perform periodic inventory check of stability chambers
Review stability data to ensure that testing and documentation is performed according to company procedures
Compile analytical data into stability reports and trend the data over the shelf-life of the products
Identify and report any out of trend or out of specification data to laboratory management
Assist laboratory management with investigations related to stability studies
Support Quality Assurance by providing stability data for submission of regulatory documents
Coordinate testing with outside laboratories, including obtaining quotes, generating purchase requisitions, shipping paperwork and required documentation
Reconciling invoices with work performed
Maintain cGMP principles and Good Documentation practices
Qualification
Required
B.S with 4-6 years experience, or M.S with 2-3 years of experience
2-5 years´ experience in a GMP laboratory setting in the pharmaceutical industry
Experience managing a stability program
Experience with Stability Software such as NovaTek, Scientek, SLIMS, etc
Good understanding of Ph. Eur/USP/NF, FDA Good Manufacturing Practices Regulations (GMP's) and OSHA safety requirements
Knowledge and experience in a cGMP environment, preferably topical pharmaceuticals
Knowledge of cGMPs, USP, and FDA (21 CFR Parts 210 and 211) regulations related to managing the stability program
Knowledge of analytical laboratory instrumentation is preferred
Strong documentation skills, with great attention to detail
Strong critical thinking and troubleshooting skills
Strong reading comprehension and listening skills
Ability to multitask and work under minimal supervision
Excellent work ethic and time management skills
Excellent oral and written communication skills
Strong computer skills (Microsoft Office)
Good organization skills with the ability to adapt to changing business priorities
Proficient in principles of data integrity
Highly motivated individual, who fosters collaboration and teamwork
Able to work overtime
Have strong Interpersonal, Facilitative, and Organizational skills
Effectively interacts with multiple functions and diverse individuals to achieve goals
Demonstrates excellent decision-making skills and the ability to prioritize appropriately
Able to work independently with minimal supervision
Company
MedPharm
MedPharm is a world-leading contract provider of topical and transdermal product design and development services.
51-200 employees
H1B Sponsorship
MedPharm has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2023 (3)
2022 (2)
2021 (2)
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
Ampersand Capital Partners
2024-07-08Acquired
2018-03-26Series Unknown
Recent News
2026-01-09
2024-11-25
Company data provided by crunchbase