Quality Control Laboratory Manager

The Quality Control Laboratory manager reports to the Director of the laboratory. The Quality Control Lab Manager will stay current on publications released by laboratory accreditation 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 pre-analytical, analytical and post analytical are in operation mode to support production.

Responsibilities:

• 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 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 reagents, standards, and samples.

• Assure that all materials, bulks, and finished goods are tested in accordance with all regulatory.

• 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, 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. 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 State 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.

Qualifications:

• 5+ years of QC lab experience in the laboratory setting required.

• Method validation experience required.

• Experience implementing and maintaining departmental metrics.

• Prior experience working with external testing laboratories.

• Bachelor’s degree in laboratory Science. Florida license required.

• Demonstrated leadership and organization skills.

• Excellent oral and technical writing skills with the ability to interface effectively and professionally at all levels.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 5 years

Schedule:

• 8 hour shift

Ability to Relocate:

• Jupiter, FL 33458: Relocate before starting work (Required)

Work Location: In person