Quality Control Manager, Microbiology
Hrybrid Potential + Competitive Salary + Growth Opportunities!!!
A leading developmental and manufacturing biopharmaceutical company is looking to expand their QC Microbiology team!
The Quality Control Manager, Microbiology will be reporting to the Director of QC Microbiology.
Manage, direct, and evaluate Microbiology testing activities of the Quality Laboratory to ensure the safety of products and to comply with quality and regulatory requirements. Support and make important decisions for the release of raw materials, in-process production, and final release of finished products. Identify potential risks associated with laboratory operations and lead teams to resolve quality issues.
If you're looking for the step up in your career and have the drive to move forward, then apply for the position of Quality Control Manager, Microbiology today!
Responsibilities
- Manage Day to day prioritization of routine, in- process, stability, and finished product testing.
- Manage Day to day support of operations of Environmental monitoring and critical utilities.
- Implement and improve quality systems to ensure compliance with testing SOPs and specifications. Use regulatory and quality guidelines such as FDA CFR, GLP, QSR, cGMP, USP, CDR and ISO as guidance for these systems
- Monitor testing techniques, testing and review accuracy of records and documentation generated
- Perform routine walkthroughs and compliance checks to verify adherence to quality guidelines. Work with inspectors in regulatory audits to represent your responsibilities
- Assess process/procedure changes proposed by others for potential impact on environmental monitoring and/or microbiology testing processes.
- Lead projects to contribute to build a team and increase efficiency, solve problems, resolve issues, create cost savings, and improve quality
- Support the environmental investigation reporting (EIR) system and assist in any related Laboratory Investigations, CAPA's, or NCR's.
- Ensure employees are trained and qualified and periodically audited. Ensure personal training requirements are met and that training records are current
- Prepare and revise SOPs and specifications. Write memos, reports, protocols, CPSs, and other appropriate documentation for proper function of the lab operation
- Lead cross-functional meetings and training sessions with manufacturing operations
- Hiring Manger for onboarding and development of team
The ideal candidates will have:
- Bachelor's Degree in Chemistry, Biological Sciences, or other relevant fields
- 5-7 years of pharmaceutical or biotech industry experience
- 3 years of Supervisory Experience
Benefits will include:
- Generous PTO
- Upward mobility
Does this sound like you? Apply today!
