Enable America Jobs

Quality Lab Manager

Job Description

Oversee and manage key functions in the Quality Unit, ensuring regulatory compliance in the analysis of raw materials, semi-finished, and finished goods for release, sale, and distribution, as well as all aspects impacting their quality. The QA/QC Supervisor is responsible for employee safety, productivity, and development, maintaining the quality of established work processes, ensuring the integrity of analytical results, and delivering excellent customer service. This role is also responsible for building a high-performing team and systems, addressing current and future needs, and developing short- and long-term quality plans for the area.

Responsibilities

• Lead department personnel and oversee quality management.

• Manage talent by building bench strength and setting clear performance and accountability objectives.

• Actively build and maintain strong relationships with QC staff and customers to meet stakeholder needs.

• Direct strategic planning and annual objective setting for the Quality unit, ensuring compliance and business alignment.

• Plan and implement new processes to keep procedures current with business needs, balancing compliance and productivity.

• Collaborate with R&D, Technical Services, Manufacturing, and Supply Chain to successfully transfer and launch new products, including validating and maintaining new assays.

• Investigate, implement CAPA, and report analytical testing results in compliance with quality management systems and escalation procedures.

• Adhere to all safety and regulatory requirements from local, state, and federal agencies (OSHA, FDA, etc.).

• Write and review technical documents and data, including raw material specifications, standard operating procedures, test methods, and change controls.

• Ensure quality performance and meet site quality targets.

• Develop and present training materials related to quality programs within and outside the quality department.

• Create and maintain master test plans in the ERP system.

• Build and grow the QC function by recruiting and developing talent.

• Ensure all QC staff are properly trained and operate in compliance with corporate and regulatory standards.

• Record and maintain all related data and records in compliance with cGMP and quality procedures.

Essential Skills

• Laboratory experience

• Quality control

• FDA and cGMP regulatory knowledge

• SAP knowledge

• Management experience

• Quality and Chemistry experience

• Lab management

• Proficient in computer literacy

• Mathematical skills

• Basic reading and comprehension

• Attention to detail

• Strong observation skills

• Self-motivation

• Excellent oral and written communication skills

• Highly organized

• Efficient in record-keeping

Additional Skills & Qualifications

• Bachelor's degree in Chemistry, Biology, or a related scientific discipline

• Master's or PhD in Chemistry, Biology, or a related scientific discipline preferred

• Over 10 years of laboratory experience, or a bachelor's degree with 8 years of related experience, or an M.S. with a minimum of 4 years of related experience

• Flexible with working hours

• Knowledgeable in FDA and cGMP policies

• Experienced with SAP and Microsoft products

Work Environment

The work environment includes a small lab with about 5-7 direct reports, mostly Chemist I and II. The team has a long tenure, is mostly self-directed, but requires strong leadership.

Pay and Benefits

The pay range for this position is $95000.00 - $105000.00

-Monday-Friday day shift schedule-Competitive salary and bonus program-Paid holidays-Paid time off programs-Industry leading 401(K) and profit-sharing program-Excellent medical, vision, dental

Workplace Type

This is a fully onsite position in Saint Joseph,MO.

Application Deadline

This position will be accepting applications until Jan 9, 2025.

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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.