Quality Assurance Control Lab Manager

Posting Date 2 months ago(10/18/2022 3:50 PM)
Requisition ID
Job Location(s)
Bloomington IN United States
Less than 10%
Position Type
Full Time
Cook Inc - Bloomington


The Quality Assurance Control Lab Manager is responsible for overseeing the QMS and Quality Assurance and Control laboratory. This position requires oversight of the day to day operations for the QAC Laboratory (Microbiology, Analytical Chemistry and Sterility Assurance) which includes employee development, organizational structure development, and financial oversight. Advisor to Cook Incorporated cross-functional teams as subject matter expert in areas of Microbiological and Analytical Product testing, Environmental Monitoring, Contamination Controls, and Sterility Assurance.


- Interface with cross-functional groups (Quality Assurance, Regulatory Affairs, Operations, & Mfg) and may serve as the subject matter expert.
- Work on sterilization validation/re-qualification requirements and the generation/review of appropriate protocols & reports.
- Manage the Microbiology, Analytical Chemistry and Sterility Assurance Laboratory Team
- Perform human resource and payroll functions for the team including screening/interviewing candidates, performance review input, etc.
- Oversee QA/QC product/facilities/critical systems microbiological, analytical chemistry and contamination control testing.
- Collaborate with Engineering, Facilities, Regulatory, etc. to provide support for environmental monitoring and microbiological testing
- Provide input in the design of manufacturing processes, controlled environments and packaging from a microbiological standpoint.
- Collaborate with other laboratory teams to troubleshoot and provide guidance on testing, method development and projects
- Ensure laboratory test methods and procedures are compliant to established standards and regulations. Anticipate standard and regulatory changes and advise/direct changes as necessary.
- Establish, maintain and review quality metrics (laboratory and environmental monitoring) and escalate quality concerns in a timely and appropriate manner.
- Effectively organize and delegate planned and unplanned projects such as; routine product, analytical and environmental testing; lot release testing; evaluation of facility, process, and product changes. Maximize productivity and ensure timely project/task completion.
- Sponsor and drive CAPA, investigations and continuous improvement projects to meet time lines with effective implementation.
- Ability to explain technical scientific information to all levels of the organization, and provide training as needed.
- Excellent technical writing and problem solving skills.
- Attend, present and provide data for meetings to include project updates and reviews.
- Participate in hiring, interviewing and on-boarding process of new hires.
- Responsible for performance management and annual reviews of direct reports.
- Authorization of weekly time sheets, concur, PTO request, department specific documents.
- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.


- BA/BS Degree in Biology, Microbiology, Chemistry, or related field required, MA/MS preferred.
- Minimum 7 years experience in a laboratory setting, 5 years experience with MA/MS.
- Minimum 2 years experience in leadership role in a regulatory controlled industry.
- Experience in CAPA, non-conformance or laboratory investigations.
- Experience in test method validations and equipment qualifications.
- Working knowledge of Microsoft Office (i.e. Word, Excel, Power point).


Physical Requirements:

- Works under general office environment conditions.
- Utilizes close visual acuity for working with computers and equipment.
- Frequently required to sit, stand, walk, and communicate.
- Personal protective equipment including safety glasses, lab coat and gloves required in some areas associated with this position.
- Minimal lifting with minimal exertion throughout the workday.


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