Description:

QC Laboratory Supervisor will, under minimal supervision of the Director of Quality, oversee inspection and analysis on raw materials, in-process samples, and finished goods to ensure compliance with cGMP/GLP standard operating procedures. The scope of responsibility for this position crosses multiple departments within Deerland (e.g. Quality Assurance, Production, Sales, etc.); therefore, the incumbent needs to collaborate with various departments and institutions. The QC Laboratory Supervisor 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. 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.

Full line: 5-15 Direct Reports

Member of: Compliance

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 exist to raise quality issues to the appropriate levels of management.

• Record, interpret, and present results to senior colleagues, customers, and vendors

• Local travel (between sites): Frequent ( greater than 50%)

• Out of state travel: Occasional ( less than 10%)

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

Education

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

Experience

Required

• Proficient in MS Word, Excel, and Power Point

• Basic mathematical and statistical skills

• Laboratory skills (e.g. pipetting, weighing, dilutions, etc.)

• Experience with any of the following: standard assay procedures, IR, HPLC, PCR, Real-Time PCR

• Leadership experience

• At least 2 years of previous laboratory experience

Preferred

• 5+ years of previous laboratory experience

• Quality Control and knowledge of cGMP / ISO 17025

Specific Skills & Abilities

• Strong attention to detail in order to produce accurate, precise, and reproducible data

• Strong leadership, analytical, organizational, and time management skills

• Task oriented and results driven

• Strong work ethic and prioritization skills

• Work collaboratively with various departments to compile, analyze, and interpret data

• Manual dexterity

• Ability to follow written protocols

• 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.

• Must possess a valid US Driver's License