QC Team Leader

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.

•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

RESPONSIBILITIES

Primary responsibilities of this role include the following:

1.Safety

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

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

2.Compliance

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

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

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

3.Productivity

oServe as primary resource for planning and scheduling of tests

oAssist analysts as needed and troubleshoot if required

oWitness analytical notebooks of peers

oConduct testing consistent with established methods/procedures

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

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

oCustodian of laboratory systems and is proactive in implementing significant system improvements and / or laboratory procedures

oCommunicate with clients, contractors, and regulatory agents as required

oProvide leadership and guidance to laboratory system owners and removes barriers to enable positive change

oFunction as the laboratory representative on multi-department project teams

oFamiliar with department and plant systems and effectively operates within systems to achieve desired results

oServe as backup to the Manager, Quality Control

4.Staff Development / Training

oIdentify areas of improvement in laboratory testing

oProvide technical training to analysts

5.Leadership

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

oAssist management with supervising project task as needed

Skills:

quality control, laboratory, chemistry, biology, microbiology, gmp, quality assurance

Additional Skills & Qualifications:

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

o5+ 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

oThorough understanding of cGMP requirements

oStrong communication, interpersonal, and organizational skills

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

oStrong technical writing and investigational skills

Experience Level:

Intermediate Level

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.