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 reportsRESPONSIBILITIESPrimary responsibilities of this role include the following:
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
Compliance
o Conduct assigned tasks in compliance with cGXP requirements, current industry standards, compendial standards, FDA expectations and internal procedureso 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
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 peerso Conduct testing consistent with established methods/procedureso Schedule and/or perform necessary validation, qualification and calibration of laboratory equipment/instrumentso Schedule method development, qualification, verification or validation according to established SOPs as well as FDA/USP/ICH guidelineso Custodian of laboratory systems and is proactive in implementing significant system improvements and / or laboratory procedureso Communicate with clients, contractors, and regulatory agents as requiredo Provide leadership and guidance to laboratory system owners and removes barriers to enable positive changeo 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 resultso Serve as backup to the Manager, Quality Control
Staff Development / Training
o Identify areas of improvement in laboratory testingo Provide technical training to analysts
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 improvemento Assist management with supervising project task as neededSkills:quality control, laboratory, chemistry, biology, microbiology, gmp, quality assuranceAdditional Skills & Qualifications:o BS in Chemistry, Biochemistry, Biology or Microbiology or related disciplineo 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 skillso Ability to work with a sense of urgency in a fast-paced environment o Strong technical writing and investigational skillsExperience Level:Intermediate LevelAbout 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 [email protected] (%[email protected]) for other accommodation options.