Quality Control Laboratory Manager

PURPOSE:

The Quality Control Laboratory Manager is responsible for the overall administration of the QC Laboratory resources, including the training and scheduling of work for the Chemistry and Microbiology Lab employees that report directly to this position. The QC Lab Manager is also responsible for direct interaction with all other departments to resolve all quality related scheduling and priority issues. In addition, The QC Lab Manager is responsible for coordinating and performing chemical and physical testing for raw materials, manufactured materials, in-process and finished products and that these meet established specifications.

JOB REQUIREMENTS:
To maintain and continuously improve the staffing and operation of the Quality Control Lab through planning, staffing, education, cross training, and communication with all departments. This position will oversee all QC Laboratory testing as it relates to components and raw materials for the day-to-day manufacturing and production schedules. The Manager will ensure that all chemists and microbiologists are qualified to utilize standard methods of analysis and numerous analytical techniques in testing these samples as well as verify the proper documentation is completed according to the guidelines and standards set forth by the FDA, GMP, SOP and all other regulatory applications of compliance. Prioritization and delegation of sample testing, equipment calibration, equipment preventive maintenance, and general laboratory hygiene and organization are required at all times as well as maintaining a comprehensive stability testing program.

JOB FUNCTIONS:

• Identify and prioritize daily work. Requires heavy interaction with other departments to identify daily testing requirements to meet the schedule/priorities
• Immediate communication to internal customers at completion of agreed schedule/priorities or when agreed schedule/priorities may be compromised (e.g., shortage of chemists (sick call), instrumentation challenges, Out of Specification results, etc).
• Schedule stability testing requirements such as to maximize use of instrumentation and meet deadlines.
• Schedule instrumentation calibration and preventive maintenance as to avoid lack of support to internal customers and meet calibration and preventive maintenance schedules.
• Schedule time off for self and direct report as to minimize the impact on the support to internal customers.
• Identify training requirements to keep abreast of current pharmaceutical testing technology and regulatory requirements.
• Train direct reports, and ensure the laboratory is clean and organized.
• Identify opportunities for improvement, optimization, efficiency, or regulatory compliance. Prepare plan to execute improvements. Share plan with supervisor.
• Be knowledgeable of all reactions, methods and calculations used in the laboratory such as to be able to explain them and derive them if needed.
• Serve as an example of professionalism to direct reports, and to internal and external customers.
• Work with external customers to resolve issues.
• Perform out of specification results investigations as required.
• Perform, as needed, all duties of direct reports and management.

PHYSICAL DEMANDS
This position requires standing approximately 50% of the time. It requires walking, bending, lifting (possibly up to 40 lbs) as well as clerical, etc. Specific vision abilities required by this job include close vision and color recognition.

ENVIRONMENTAL DEMANDS:
This position requires daily working with hazardous and toxic chemicals, dust, and fumes necessitating use of personal protective equipment such as safety glasses, lab coat, face shields, respirators, fume hoods, etc. The company makes PPE available.

BASIC QUALIFICATIONS:

• A four-year science degree with Chemistry major or minor preferred.
• Experience or training in management and communication skills is preferred.
• A minimum of five years of analytical experience in a pharmaceutical QC laboratory is preferred.
• Preferably two years of experience in a leadership position.

All employees will follow and uphold policies as set out and signed in Employee Handbook

Job Type: Full-time

Pay: $65,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Retirement plan
• Vision insurance

Work Location: In person

Salary : $65,000