QC Team Leader
: Job Details :

SUMMARY OF POSITION The Team Leader Quality Control:

• Leads and manages activities supporting the laboratory function in executing daily operations and testing necessary to support commercial products.
• Anticipates and resolves problems independently while conforming to SOPs and GMP regulations
• Monitors the scientific and financial progress of projects that they are assigned
• May have responsibility for a laboratory group or function and may have direct reports

ORGANIZATION STRUCTURE The Team Leader Quality Control reports to the Manager Quality Control or Director QC. Any of 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

RESPONSIBILITIESPrimary responsibilities of this role include the following:

Safety

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

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

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 are completed within established target completion dates

Ensure that the Quality Control staff have been appropriately trained before performing a GMP task

Productivity

Serve as 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

Custodian of laboratory systems and is proactive in implementing 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 removes barriers to enable positive change

Function as the laboratory representative on multi-department project teams

Familiar with department and plant systems and effectively operates 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 through example the expected professional conduct, display integrity and honesty, inspire staff to excel and foster an environment of continuous improvement

Assist management with supervising project task as needed

QUALIFICATIONS

BS in Chemistry, Biochemistry, Biology or Microbiology or related discipline

5+ years experience in a laboratory environment (quality control or similar pharmaceutical industry experience preferred), or MS in Chemistry, Biochemistry, Biology or Microbiology or related discipline and 3+ years experience

Thorough understanding of cGMP requirements

Strong communication, interpersonal, and organizational skills

Ability to work with a sense of urgency in a fast-paced environment

Strong technical writing and investigational skills

GMP DECISION-MAKING AUTHORITY The Team Leader Quality Control is responsible for decisions related to:

When an investigation is warranted

When analyst training is warranted

Disposition of laboratory test results and samples/batches

Prioritization of staff work assignments and testing schedules

Suitability of analytical equipment/instruments for use

When a Change Control is warranted

When an analyst is qualified to perform testing

Applies advanced theoretical knowledge, education, experience, and training in conjunction with technical resources to troubleshoot and resolve problems

This role will offer a base salary that is commensurate with experience and demonstrated skills in the $70,000-$80,000.00 range. An Equal Opportunity Employer, including disability/vets.