OVERALL OBJECTIVE: Audit and inspect operational activities for compliance to cGMPs, SOPs, and other written quality standards.
- Monitors production areas for cleanliness and adherence to cGMPs/SOPs to assure readiness for commencement and completion of production activities.
- Reviews batch record for clarity, correctness, completeness, and compliance.
- Performs inspection sampling in order to assess product adherence to quality standards.
- Interacts with Quality, Operations, Clinical Projects, and Logistics personnel to address quality issues.
- Initiates and investigates planned and unplanned deviations, as required.
- Assists in cGMP, SOP, and job skill training of quality control and other ALMAC CLINICAL SERVICES personnel.
- Ensures activities of company personnel, including the quality control group, center on maintaining company compliance to cGMPs, SOPs, and other approved written instructions.
- Utilizes operational techniques and activities to ensure product adherence to written internal and external quality standards.
- Ability to sit and concentrate for extended periods.
- 1-3 years experience in clinical supplies or pharmaceutical/hospital setting.
- GMP knowledge
- Attention to detail, Computer proficiency
- Excellent communication skills.
- Associate or Bachelors degree desired
Other Requirements:
- Candidates responding to this posting must currently possess the eligibility to work in the United States.
- Successfully passing a drug screen, vision test, employment, education, & criminal background checks.
Candidates debarred/prohibited from employment in the pharmaceutical industry under the Generic Drug Enforcement Act of 1992 are not eligible for employment with Almac. Candidates must provide salary requirements for consideration.
No relocation or interview travel expenses currently available.
