Maintain the Stability Program to the current regulatory standards. Ensure that all external testing for the company is shipped in a timely manner and track that results are received.
location: Statesville, North Carolina
job type: Permanent
salary: $35,000 - 40,000 per year
work hours: 9 to 5
Manage stability program including:
- Maintaining the stability calendar o Ensure all samples are pulled and sent out at the correct time points
- Create stability protocols and reports o Track study data and results throughout testing
- Create submission forms and all needed documentation for lab samples sent out for third party testing.
- Prepare and ship all Quality Control samples that require testing by external labs.
- Track, receive, and distribute all external testing results to ensure that results are received in a timely manner
- Provide back up for physical testing of in-process, bulk, finished product, and raw material and stability samples. Testing includes organoleptic, pH, specific gravity and titrations.
- Communicate task status to QC Coordinator or designee.
- Assist with other Quality functions as directed.
- 1 -3 years' experience in a Quality laboratory for food or drug manufacturing.
- Bachelor's degree in science related field preferred, or a combination of education and experience.
- Knowledge of cGMP stability program preferred
- Understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
- Strong computer skills with the ability to create spreadsheets and excellent typing skills
- Able to work without supervision and multi-task in a fast paced environment
- Dependable and detail-oriented
- Must demonstrate good interpersonal skills and teamwork awareness
- Strong documentation skills are required, including writing reports and protocols.
skills: Chemistry, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.