Over de functie
About the job
The Quality Control Laboratory manager reports to the Director of Quality. The Quality Control Lab Manager will stay current on publications released by USP, FDA and other pertinent regulating bodies to ensure the Quality Control Laboratories and associated activities throughout the facility are compliant and continuously improved upon. The Quality Control Laboratory Manager will ensure the analytical/microbiology laboratories are in operation mode to support production and the release of product.
Duties & Responsibilities
- Responsible for managing the QC laboratory in accordance with cGMP, customer and company requirements. Lead, organize and maintain all department and laboratory processes, procedures and administrative duties.
- Act as liaison with external parties on matters relating to QC testing status, approvals, rejections, documentation status, and any other QC matters to support all internal departments and customers.
- Develop and implement systems designed to support assay development, stability, raw material and finished product testing.
- Facilitate the evaluation of new testing applications and instrumentation. Assist in the purchase and commission of analytical and microbiology instrumentation. Ensure there are efficient instruments for the workload of samples.
- Assure adequate communication of priorities exists between the lab and other departments and within the lab.
- Provide guidance to resolve problems with instruments, test methods, lab chemicals, standards, and samples.
- Assure that all raw materials, bulks, and finished goods are tested in accordance with all regulatory, Fagron, and customer requirements, as applicable.
- Prepare justification for new lab equipment. Prepare purchase orders and coordinate authorization and procurement. Arrange installation and qualification.
- Manages process optimization program that includes continual improvement programs for analyses, human capital development and management systems
- Overall responsible for environmental monitoring program, including ensuring weekly monitoring and reporting is conducted and generating Impact Risk Assessments and quarterly/annual reports
- Overall responsible for stability programs and ensuring execution within required timelines. Continuous management, development and improvement of stability program.
- Overall responsibility to manage method validations/qualifications.
- Take lead responsibility with contract laboratories supporting outsourced testing, method development and assay validation activities.
- Investigate deviations and write exception documents as required, utilizing problem solving tools as needed. Demonstrate familiarity with product specifications, process reference files, code of federal regulations, and compendia requirements.
- Responsible for investigating and processing Deviations, Out of Specifications, and Out of Trend, QC events. Identify and report non-conformances/deviations/out-of-specification events.
- Other duties as assigned
Maak het verschil
Education/ Experience Requirements:
- 5+ years of QC lab experience in biotech/pharmaceutical industry in a cGMP environment is required.
- Method validation experience required.
- Experience implementing and maintaining departmental metrics
- Prior experience working with external testing laboratories and CMO development and manufacturing partners is highly desirable.
- Bachelor’s degree in Science related field required.
- Demonstrated leadership and organization skills
- Excellent oral and technical writing skills with the ability to interface effectively and professionally at all levels
- Ability to develop and lead a high performing team.
- Communicate clear work plans, coordinate staff schedules, training and standardize work hours among the staff when possible.
- Work with various staff members to evaluate and improve processes, through informal and formal channels.
- Ability to work on cross functional teams and apply influencing skills in a matrix environment
- Must be able to develop solutions for simple and complex problems, which require a high degree of ingenuity, creativity and innovation. Challenges are frequently unique, and solutions may serve as precedent for future decisions, which effect the entire organization.
- Operate precision measuring tools.
Wat bieden wij?
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron US offers its associates competitive compensation and a wide range of benefits including a 401(k) plan with a generous company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.