Overview
Quality Assurance Manager Jobs in Lockbourne, OH at Crane Solutions LLC
About Nucleus Biologics
At Nucleus Biologics, we are passionate about supporting the development of groundbreaking discoveries and improving the quality of life for patients. Our cell culture products and services fuel today’s therapies and tomorrow’s innovations.
Cell culture media is a critical raw material used in the development of cell-based projects. As the Cell Performance Company™, we are the leading provider of custom cell growth media, tools, and technologies that support every stage of development from research through commercialization. We are committed to delivering premium products and services through a transparent, consistent, and proven supply chain that eliminates variability.
About the role
The Senior QC Analyst is responsible for executing quality control activities, including in-house environmental monitoring and water testing, final release and stability testing, and incoming quality inspections. This role ensures compliance with applicable regulations and internal quality standards while supporting laboratory operations, data analysis, and inventory management. The Senior QC Analyst also facilitates outsourced testing and contributes to maintaining an efficient and compliant QC laboratory.
What you’ll do:
Environmental Monitoring & Water Testing:
Perform in-house environmental monitoring of classified and non-classified areas, including air, surface, and personnel monitoring.
Conduct high-purity water testing in accordance with USP <645> and other applicable standards.
Maintain and document environmental and water testing results, ensuring compliance with internal procedures and regulatory expectations.
QC Testing & Product Release:
Perform QC final release testing for raw materials, in-process, and finished goods per established specifications.
Execute stability testing and support stability studies by collecting, testing, and documenting data.
Perform cell-based assays to assess product potency and functionality as required.
Support functional assay development and validation in collaboration with R&D and manufacturing teams.
Ensure timely review and approval of test results, escalating deviations or out-of-specifications (OOS) as necessary.
Incoming Quality Inspection:
Conduct visual and physical inspections of incoming raw materials, components, and packaging to ensure compliance with approved specifications.
Maintain accurate documentation of inspection results, release decisions, and nonconformance findings.
Sample Management & Outsourced Testing:
Prepare, package, and coordinate the shipment of samples for external contract laboratory testing.
Track outsourced test results and ensure timely follow-up for reporting and data review.
Data Analysis & Trending:
Compile, analyze, and trend QC test data to identify potential quality issues, process improvements, or trends requiring further investigation.
Generate reports and present findings to support quality metrics and continuous improvement initiatives.
Laboratory Maintenance & Inventory Management:
Maintain QC laboratory supplies and reagents at optimal inventory levels, ensuring uninterrupted operations.
Oversee cleaning and general upkeep of the QC laboratory, ensuring compliance with Good Laboratory Practices (GLP) and regulatory requirements.
Support routine calibration, qualification, and maintenance of laboratory equipment.
Qualifications:
Requirements
Bachelor’s degree in Chemistry, Microbiology, Biology, or a related field. A combination of education and/or relevant job experience may be considered.
3-5 years of experience in a QC laboratory within the pharmaceutical, biotechnology, or related regulated industry.
Experience with environmental monitoring, water testing, and microbiological/chemical testing methodologies preferred.
Familiarity with regulatory guidelines (e.g., USP, cGMP, FDA, ISO 9001/13485).
Strong organizational skills with attention to detail and the ability to manage multiple tasks.
Proficiency in data analysis and trending tools, with experience in LIMS or similar QC systems a plus.
Excellent communication and documentation skills, with the ability to work cross-functionally in a fast-paced environment.
Hands-on experience with aseptic technique and mammalian cell culture, including maintenance and expansion of cell lines.
Experience performing or supporting functional assays such as proliferation, cytotoxicity, differentiation, or reporter-based readouts is strongly preferred.
Additional Skills
Ability to independently develop and manage projects and timelines
Ability to communicate effectively both orally and in writing and to establish and maintain productive working relationships
Strong attention to detail and process mindset
Ability to exercise independent judgment consistent with Company guidelines
Excellent verbal and written communication skills.
Familiar with statistical process control methods.
Physical Requirements
Ability to hear and speak to employees and external associates on the phone and in person.
Ability to see the letters and numbers on a personal computer screen and on memos, reports and other documents (near vision)
Ability to walk and/or drive between buildings on campus, up to .3 miles for San Diego based positions
Travel Requirements
May require travel to and from Nucleus Biologics offices or customer/vendor locations based on position
NOTE: The above statements are intended to describe the general nature and level of work being performed by incumbents. They are not intended to be an exhaustive list of all responsibilities, duties and skills required by all incumbents. Incumbents may perform other duties as assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Management retains the right to add to or change the duties of the position at any time.
The pay range for this role is:
70,000 – 80,000 USD per year(San Diego)
Show more
Title: Quality Assurance Manager
Company: Crane Solutions LLC
Location: Lockbourne, OH
