Our client, a leading pharmaceutical company, is hiring a Stability Associate Scientist on a contract basis.
- Provide administrative support to enrollment activities (form creation, archival, tracking, etc)
- Draft stability requirement documentation and support management of enrollments as required.
- Enrollment forms: initiate GMP forms, and help ensure completion, review, and approval by contributing functions.
- Escalate information regarding impact to stability program promptly.
- Support activities of Stability Third Party sample storage facility including but not limited to inventory control, sample receipt support, labeling, sample destructions, sample pulls and oversight of sample deliveries, etc.
- Ensure training requirements are met.
- Maintain cGMP practices and comply with HA expectations.
- Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry, a related discipline or its equivalent.
- Able to prioritize objectives from multiple projects, adhering to scheduled timelines.
- Work independently and contribute to a team based environment; promoting a high commitment to business goals and objectives.
- Computer skills required: Microsoft Office applications. LIMS skills are desired.
- Excellent organizational skills.
- A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to quality control laboratories in a biologics manufacturing facility.
Please contact me directly if you are interested in learning more about this opportunity or to discuss our referral program if you know anyone that may be interested.