Piper Companies is looking for a Quality Manager, Microbiology for 2nd shift to ensure compliance of operations, assessing the conformance of manufacturing operations to GMP requirements and Microbiology quality of products for a Pharmaceutical Manufacturer in Boothwyn, PA.
Responsibilities for the Quality Manager, Microbiology include:
- Responsible for coordination of QA/QC specific to Microbiology staff and their Environmental Monitoring (EM) functions
- Maintain the EM program, Performs EM sampling as needed
- Participate in lab design and set-up, including equipment set-up/qualification
- Microbiological requirements of the Raw Material testing program
- Product release Testing: Sterility/Endotoxin and other Microbiological tests as needed
- Management review of QA Microbiology investigations, laboratory deviations, OOS / OOT results, etc.
- Reviews and updates Standard Operating Procedures (SOPs)
- Performs peer review and trending of data.
- Participates in execution of validation protocols.
- Reviews laboratory investigation reports (inclusive if provided by third party purveyor).
- Helps with receipt / sampling / testing / release of raw materials and products. Monitors, performs and documents sampling / testing and inspection of raw materials / components / in-process samples and documents the results in compliance with cGMP and company procedures.
- Accurately performs in-process inspections.
- Reviews completed batch records and issues batch records and associate forms to production.
- Helps conduct investigations of process deviations
Qualifications for the Quality Manager, Microbiology include:
- Bachelor’s degree in a life science or related field of study.
- 7-10 years of related experience in cGMP
- Previous experience in operating and adjusting various equipment for purposes such as performing standardized test or operations, requiring considerable training and experience
- Previous experience within QA/QC and Environmental Monitoring.
- Previous experience with Sterility and Endotoxin testing as well as with validation of standard and rapid microbial methods.
- Previous experience entering information into a data warehouse system (i.e. Cornerstone LMS)
- Proficiency in MS PowerPoint
Compensation for the Quality Manager, Microbiology include:
Please send resume to KarenPallone: firstname.lastname@example.org