This description is intended to be illustrative of the major duties performed by the employee assigned to this position. Performs other duties as assigned.
This position reports to the Quality Manager or Supervisor. The role is responsible for performing quality activities and maintaining a quality laboratory environment in a sterile pharmaceutical manufacturing facility. The candidate should have an understanding of raw material requirements, laboratory environments, and cGMP requirements. The position requires an individual who works independently and in a team environment, with attention to detail, and maintains communication with other functional areas and sites.
Responsible for performing daily quality functions including:
- Perform environmental monitoring in an aseptic environment.
- Incubate and enumerate environmental monitoring plated media.
- Assist with sample submissions to contract laboratories.
- Responsible for the accurate recording, review, and storage of in-house and contract laboratory data.
- Ensure timely completion and subsequent review of routine laboratory data.
- Assist with facility and personnel qualifications in the form of media fill incubation and observation of results.
- Support investigations when deviations or errors occur.
- Participate in reviews of process performance, product quality, and advocating continual improvement.
- Ability to follow SOPs, forms, operational GMP training, and perform quality activities.
- A minimum of 20/30 (corrected or uncorrected) vision.
EXPERIENCE AND NECESSARY SKILLS:
- Minimum 0-2 years in a quality position at a cGMP or GMP facility. Sterile injectable product preferred. Food, cosmetic, or pharmaceutical will be considered.
- High School Diploma or equivalent. College diploma with a focus on sciences preferred.
- Ability to adapt to changing priorities and circumstances.