Location: Buena, NJ
The Quality Control Stability Coordinator is responsible for day to day operations related to stability program, as well as additional departmental duties as described below.
Reporting Relationships: Individual Contributor
- Execute the day to day operations of the stability program for drug product, including stability sample set-down and pull requirements, ensuring a timely, effective and compliant operation to meet regulatory requirements.
- Log in and delivering stability samples to the appropriate laboratories with the respective specification sheets.
- Audit/maintain visibility of the cycle time requirements for the stability testing program to ensure that all testing is completed within the required time frame.
- Ship samples to Outside Testing Laboratories (i.e. AET/Preservative effectiveness testing samples, raw materials, and other samples as needed).
- Manage the data generated from stability studies.
- Write and revise stability protocols and complete stability reports.
- Liaise with the department members as needed to accomplish tasks in a timely manner.
- Stability data trending and graphing.
- Ensure that suitable written records and work undertaken are kept in accord with cGMP and company procedures.
- Other duties as assigned.
- Minimum of a high school diploma, BA/BS preferred, with 2 years of experience in a cGMP/regulated environment or equivalent education and experience.
- Good communications skills and be experienced in Microsoft programs; Word, Excel, and Access.
- Excellent multi-tasking and organizational skills.
- Excellent organizational skills.
- Demonstrated ability to work on multiple projects and meet timelines and detail oriented.
- Collaborative working style, demonstrates professionalism, cooperation and willingness to support team and company priorities.
- Well-developed interpersonal skills. Ability to get along with diverse personalities.
- Good written and oral communication skills.
- Physical Demands
- Ability to lift, push and pull 25 pounds
- Temperature variations
- Sit and stand for long periods
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.