QC Team Leader - Norwich, United States - Actalent

Actalent Norwich, United States

23 hours ago

Full time

Description

Actalent Scientific is Hiring

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

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

Responsibilities:

Primary responsibilities of this role include the following:

1. Safety

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

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

2. Compliance

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

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

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

3. Productivity

o Serve as primary resource for planning and scheduling of tests

o Assist analysts as needed and troubleshoot if required

o Witness analytical notebooks of peers

o Conduct testing consistent with established methods/procedures

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

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

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

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

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

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

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

o Serve as backup to the Manager, Quality Control

4. Staff Development / Training

o Identify areas of improvement in laboratory testing

o Provide technical training to analysts

5. Leadership

o 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

o Assist management with supervising project task as needed

Skills:

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

Additional Skills & Qualifications:

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

o 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

o Thorough understanding of cGMP requirements

o Strong communication, interpersonal, and organizational skills

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

o Strong technical writing and investigational skills

*GMP DECISION-MAKING AUTHORITY*

The Team Leader Quality Control is responsible for decisions related to:

o When an investigation is warranted

o When analyst training is warranted

o Disposition of laboratory test results and samples/batches

o Prioritization of staff work assignments and testing schedules

o Suitability of analytical equipment/instruments for use

o When a Change Control is warranted

o When an analyst is qualified to perform testing

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

About Actalent

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.

Diversity, Equity & Inclusion

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 for other accommodation options.

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