QC Lab Manager - Kennesaw, GA

Job Description

QC Lab Manager - Kennesaw, GA
This is a full-time, exempt position.

Nature and Scope:
The Laboratory Manager will, under minimal supervision of the Site QFS Manager, oversee inspection and analysis on raw materials, in-process samples, and finished goods to ensure compliance with cGMP/GLP and safety standard operating procedures. The scope of responsibility for this position crosses multiple departments within ADM (e.g. Quality Assurance, Production, Sales, etc.); therefore, the incumbent needs to collaborate with various departments and institutions. The Laboratory Manager will lead, facilitate, and support the improvement of staff through regular communication regarding expectations, laboratory technique, and training. A successful candidate will be expected to review laboratory logbooks and testing documentation for accuracy and legibility in accordance with SOP's. This function will oversee the compliance of the Laboratory including cGMP, GLP, ISO 17025, EPA, and TGA / PICs requirements. They will continuously evaluate and ensure commercial, financial, and other pressures do not compromise the impartiality of the lab. This role will also manage procurement, qualification, maintenance, and repair of laboratory equipment. Additional functions include reviewing and creating Certificates of Analysis (COAs) and Result Reports; provide technical support to internal and external customers and/or vendors; support customer acquisition testing including chemical assays and microbiological assays.

Major Accountabilities:
The responsibilities of a Laboratory Manager include, but are not limited to the following:
Management

• Lead and manage department staff through effective planning, mentoring, directing and coordination of development activity
• Lead and facilitate initial and periodic training of QC Chemists, Microbiologists to ensure standard laboratory practices, techniques, and adherence to cGxP and other applicable regulations and standards (21 CFR, 11, 111 and 117, ISO17025 and the requirements of TGA PIC/s)
• Oversee the development, transfer, improvement, validation, and implementation of new laboratory methods
• Lead or assist in the development of all laboratory standard operating procedures
• Communicate and enforce laboratory quality requirements to all personnel working in the lab and ensure that they are completed per GMP, GLP and ISO 17025 standards
• Monitor adherence to the laboratory budget and provide reports, as required, to department administration
• Develop and drive budgetary cost reduction strategies.
• Prepare and perform personnel evaluations and competencies and administer performance reviews.
• Provide improvement plans/disciplinary action where necessary
• Coordinate objectives with production procedures in cooperation with other managers to maximize product reliability and minimize costs
• Ensure a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
• Record, interpret, and present results to senior colleagues, customers, and vendors
• Develop and report laboratory metrics to monitor the performance and capacity of the laboratory
• Local travel (between sites): Frequent (> 50%)
• Out of state travel: Occasional (

Quality Control Responsibilities

• Oversee the scheduling and performance of laboratory tests in a manner such that results are accurate, precise, and reproducible
• Oversee (including approving or rejecting) the inspection and analysis of raw materials (including packaging components), in-process samples, and finished goods and ensure that it is conducted in accordance with cGMP/GLP standard operating procedures
• Lead investigations related to contamination and procedural or analytical deviations or errors in the laboratory and ensure corrective actions are developed and implemented
• Oversee the validation, qualification, maintenance, and repair of laboratory and testing equipment, ensuring all maintenance and repairs are adequately performed, documented, and reviewed for compliance with design specifications.
• Review and approve all laboratory control processes associated with the production and process control system
• Ensure all tests and examinations required under 111.75 are conducted and results delivered in accordance to established timelines.
• Determine whether specifications established under 111.70(a) are met
• Review and approve the results of all tests and examinations required under 111.75
• Conduct material review and disposition decisions if an established specification is not met.
• Document all material review and disposition decisions at the time of performance
• Ensure laboratories are well-stocked and resourced via maintenance of reagent and equipment stock and ordering of necessary materials
• Coordinate with laboratory vendors for supply or equipment issues, new equipment or supply purchases and annual cost reviews
• Create, analyze, verify, and approve result reports
• Create, verify, and sign-off on COAs upon successful finished goods testing
• Oversee proper storage of retains
• Enforce proper laboratory safety protocols and regulatory requirements for OSHA, NSF, and other agencies Deerland Probiotics and Enzymes is associated with (e.g. ISO)
• Maintain familiarity with current scientific literature and technologies
• Approve and monitor any contract labs, analysts, or other providers of GMP related outsourced activities
• Act in partnership with the Quality Manager to lead all ISO 17025 and regulatory audits related to the laboratory operation
• Submit performance improvement initiatives and drive efficiencies and continuous improvement within the laboratory operation
• Other Duties as Required

Qualifications

• Bachelor of Science in Biochemistry, Biology, Chemistry, or equivalent

Required

• Experience with ISO and cGMP standards
• Background overseeing laboratory facilities and equipment
• Working knowledge of ERP systems and Microsoft Office Software
• Prior experience working with external testing laboratories
• At least 5 years of previous laboratory management experience

Preferred

• 7+ years of previous laboratory experience
• Quality Control and knowledge of 21 CFR 111 / ISO 17025

Specific Skills & Abilities

• Strong attention to detail in order to produce accurate, precise, and reproducible data
• Excellent verbal and technical writing skills with the ability to interface effectively and professionally at all levels.
• Task oriented and results driven
• Strong work ethic and prioritization skills
• Work collaboratively with various departments to compile, analyze, and interpret data
• Demonstrated leadership and organization skills
• Ability to adapt and drive change
• Ability to work in a fast-paced environment
• Excellent written and oral communication skills - ability to make presentations and/or give presentations
• Must be able to lift 25 lbs.

Excited about this role but don't think you meet every requirement listed? We encourage you to apply anyway. You may be just the right candidate for this role or another one of our openings.

ADM requires the successful completion of a background check.

REF:95334BR

About ADM

At ADM, we unlock the power of nature to provide access to nutrition worldwide. With industry-advancing innovations, a complete portfolio of ingredients and solutions to meet any taste, and a commitment to sustainability, we give customers an edge in solving the nutritional challenges of today and tomorrow. We're a global leader in human and animal nutrition and the world's premier agricultural origination and processing company. Our breadth, depth, insights, facilities and logistical expertise give us unparalleled capabilities to meet needs for food, beverages, health and wellness, and more. From the seed of the idea to the outcome of the solution, we enrich the quality of life the world over. Learn more at www.adm.com.

#IncludingYou

Diversity, equity, inclusion and belonging are cornerstones of ADM's efforts to continue innovating, driving growth, and delivering outstanding performance. We are committed to attracting and retaining a diverse workforce and create welcoming, truly inclusive work environments - environments that enable every ADM colleague to feel comfortable on the job, make meaningful contributions to our success, and grow their career. We respect and value the unique backgrounds and experiences that each person can bring to ADM because we know that diversity of perspectives makes us better, together.

We are committed to ensuring all qualified applicants receive consideration for employment regardless of race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.

We welcome everyone to apply, especially those individuals who are underrepresented in our industry, as we strive to ensure our workforce represents the world that we help to feed: people of color, women, gender non-conforming, LGBTQIA+, veterans and persons with disabilities. For more information regarding our efforts to advance Diversity, Equity, Inclusion & Belonging, please visit our website here: Diversity, Equity and Inclusion ADM.

Benefits and Perks

Enriching the quality of life for the world begins by taking care of our colleagues. In addition to competitive pay, we support your diverse needs with a comprehensive total rewards package to enhance your well-being, including:

• Physical wellness - medical/Rx, dental, vision and on-site wellness center access or gym reimbursement (as applicable).
• Financial wellness - flexible spending accounts, health savings account, 401(k) with matching contributions and cash balance plan, discounted employee stock purchasing program, life insurance, disability, workers' compensation, legal assistance, identity theft protection.
• Mental and social wellness - Employee Assistance Program (EAP), Employee Resource Groups (ERGs) and Colleague Giving Programs (ADM Cares).

Additional benefits include:

• Paid time off including paid holidays.
• Adoption assistance and paid maternity and parental leave.
• Tuition assistance.
• Company-sponsored training and development resources, such as LinkedIn Learning, language training and mentoring programs.

*Benefits may vary for bargained locations, confirm benefit eligibility with your recruiter.

Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours.

If hired, employees will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

The pay range for this position is expected to be between: