Base pay range
$40.00/hr - $41.00/hr
Duration: 6+ Months
Location: Old Oxford Road, Durham, NC, 27712
Qualifications
- Associate’s degree preferably in a science field is required.
- Bachelor’s degree in biological sciences is preferred.
Required Experience and Skills
- At least 1 year of relevant post‑degree work experience in Environmental Monitoring, Aseptic Manufacturing or Microbiological Laboratory Operations.
- Evidence of good oral and written communication skills.
- Attention to detail, flexibility and an awareness of production and attendant quality control problems.
- Basic understanding of GMPs and of regulatory requirements as they apply to the vaccine, sterile pharmaceutical or related fields.
- Physical requirements: sit, stand, move within workspace for extended periods; perform repetitive tasks including frequent hand‑to‑finger manipulations, grasping, pushing and pulling; lift up to 50 pounds.
Preferred Experience and Skills
- EM Sampling in a pharmaceutical setting (not EPA) with GMP experience.
- Quality Control, Quality Assurance and/or cGMP experience.
- Prior experience with GLIMS.
- Shift: Ability to work 4 * 10‑hr shift (Wed‑Sat) 4pm‑2:30am EST.
Responsibilities
- Maintain the Environmental Monitoring (EM) program, including the following:
- Collection and testing of qualified Utility systems such as Clean Steam, WFI, and compressed gases.
- Execute environmental sampling of Classified Areas, including active air sampling, surface sampling, and non‑viable air sampling.
- Provide data entry, review and approval as required.
- Provide summaries of test results to appropriate personnel.
- Compile and evaluate environmental data for adverse trends.
- Directly support Performance Qualification activities.
- Perform routine monitoring of Personnel and compile and author Annual Reviews.
- Author and summarize re‑qualification, performance qualification, and special study protocols.
- Perform monthly and weekly sample accountability.
- Submit LIMS sample rejections and equipment calibration and management tasks.
- Filing data sheets and document control of logbooks and other duties requested by management.
- Read EM Plates, TOC analysis, Conductivity, Gas Testing, LIMS, SAP, Trackwise, investigations with GMP experience.
Seniority level
Associate
Employment type
Contract
Job function
Research
Industry
Pharmaceutical Manufacturing