QC Team Lead

If interested in learning more about this opportunity, please send resumes and phone call availability directly to Shannon: sfitch@ actalentservices.com

Job Description

The Team Leader Quality Control leads and manages activities supporting the laboratory function in executing daily operations and testing necessary to support commercial products. This role anticipates and resolves problems independently while conforming to SOPs and GMP regulations. The Team Leader monitors the scientific and financial progress of assigned projects and may have responsibility for a laboratory group or function, including direct reports.

ORGANIZATION STRUCTURE

The Team Leader Quality Control reports to the Manager Quality Control or Director QC. The following Quality Control staff may report to the Team Leader Quality Control:

- Chemist-analyst 1, 2, and 3

- Microbiologist 1, 2, and 3

- Metrologists

RESPONSIBILITIES

Safety

- Participate in weekly/monthly safety training, identify potential safety hazards, implement appropriate safety improvements, and take part in investigations of safety-related incidents

- Perform job functions in a safe manner consistent with site safe practices and regulatory requirements (e.g., OSHA)

Compliance

- Conduct assigned tasks in compliance with cGXP requirements, current industry standards, compendial standards, FDA expectations, and internal procedures

- Ensure investigations are conducted in a timely manner and completed within established target completion dates

- Ensure that Quality Control staff are appropriately trained before performing GMP tasks

Productivity

- Serve as the primary resource for planning and scheduling of tests

- Assist analysts as needed and troubleshoot if required

- Witness analytical notebooks of peers

- Conduct testing consistent with established methods/procedures

- Schedule and/or perform necessary validation, qualification, and calibration of laboratory equipment/instruments

- Schedule method development, qualification, verification, or validation according to established SOPs as well as FDA/USP/ICH guidelines

- Act as custodian of laboratory systems and proactively implement significant system improvements and/or laboratory procedures

- Communicate with clients, contractors, and regulatory agents as required

- Provide leadership and guidance to laboratory system owners and remove barriers to enable positive change

- Function as the laboratory representative on multi-department project teams

- Be familiar with department and plant systems and effectively operate within systems to achieve desired results

- Serve as backup to the Manager, Quality Control

Staff Development / Training

- Identify areas of improvement in laboratory testing

- Provide technical training to analysts

Leadership

- Lead by example, demonstrate expected professional conduct, display integrity and honesty, inspire staff to excel, and foster an environment of continuous improvement

- Assist management with supervising project tasks as needed

Hard Skills

• Planning and scheduling of tests
• Troubleshooting
• Validation, qualification, and calibration of laboratory equipment/instruments
• Method development, qualification, verification, or validation
• Compliance with cGXP requirements, industry standards, FDA expectations, and internal procedures

Soft Skills

• Leadership
• Problem-solving
• Communication
• Staff development
• Integrity and honesty

Job Type

This is a permanent position.