Job Title

QC Lab Supervisor

Reports To

Quality Control Director

Scope of Supervision

QC Lab

YOUR PURPOSE

The Quality Control Lab Supervisor oversees the day-to-day operations of both the Microbial and Analytical Laboratory while ensuring regulatory compliance.

POSITION RESPONSIBILITIES

· Supervise all aspects of the day-to-day activities of the analytical laboratory.

· Oversee and facilitate the workloads of the laboratory to meet company expectations.

· Serve as technical advisor for laboratory staff.

· Responsible for supervision and training of laboratory staff.

· Will perform testing, as necessary, according to SOP’s, compendia or others methods on laboratory samples.

· Assist in implementing quality and regulatory requirements (i.e., cGMP, FDA, CFR’s, USP, etc.).

· Assure the laboratory operates in a compliant manner consistent with cGMP and company policies.

· Ensure compliance with testing techniques and accuracy of all records and documentation in the laboratory; monitor and maintain laboratory data, including any electronic data, notebooks or forms.

· Prepare, review, and revise, as required, SOP’s and specifications. Write memos, reports, protocols and other appropriate documentation for proper functioning of the lab.

· Implement method development and validation, including preparation, review and approval of Protocols and Summary Reports.

· Ensure OOS events are investigated and resolved in a timely manner.

· Manage the stability program for all applicable products.

· Manage analytical and qualitative reference standards, including identifying appropriate standards and monitoring storage and inventory.

· Maintain an active role on continuous improvement teams to identify opportunities to increase efficiency and effectiveness, and reduce costs (e.g., scheduling efficiencies, out-sourced testing, and supplies).

· Manage hazardous materials waste management program to meet federal and state regulations.

· Writes and/or reviews Protocols and Summary Reports.

· All other duties as assigned.

· Willing to work overtime, holidays and weekends as requested by management.

MINIMUM QUALIFICATIONS

Education:

BS degree or higher in Chemistry or related field or equivalent experience.

Experience:

· Minimum 7 years of experience in cGMP environment Drugs, Cosmetics, or Dietary Supplements.

· Minimum 3 years of supervisory experience.

Knowledge, Skills and Abilities:

· Excellent bench skills

· Excellent organizational skills

· Strong analytical knowledge

· Team development, motivational and leadership skills

· Writing skills (reports, SOP’s, protocols, etc.)

· cGMP / GLP background is required

· Computer skills to include full competence with MS Word, PowerPoint, Outlook, Excel, and Access

· Strong communication skills

Training, Certification or License:

· Department cGMP and SOP requirements

Job Type: Full-time

Pay: $65,000.00 - $75,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Relocation assistance
• Retirement plan
• Vision insurance

Experience level:

• 7 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• Weekends as needed

Ability to Relocate:

• Largo, FL 33773: Relocate before starting work (Required)

Work Location: In person