SUMMARYUnder the guidance of the QC Manager, the QC Lab Supervisor will be responsible for planning, organizing, directing, and evaluating routine and non-routine activities of the QC chemistry and microbiology staff in support of operations, planning, production, R&D, QA and in full compliance with cGLP/cGMP regulations and NAI policies.
RESPONSIBILITIES- Principal responsibilities:
- Ensures QC staff receive training in cGMPS, SOP's, and company policies and as per associated JD curriculum.
- Writes, revises, and reviews QC SOPs.
- Develops and implements corrective actions to support continuous improvement activities in the company.
- Manages OOS notifications and investigations from contract laboratories.
- Oversee the day-to-day laboratory operations to ensure that production and R&D needs are met.
- Plan the daily and weekly work assignments of the chemistry and microbiology analysts.
- Collaborate with the lab manager and administrative team to assign and revise testing priorities.
- Provides technical guidance to staff in the performance of all approved laboratory procedures.
- Review analyst work and notebook, prepare final reports. Ensure that proper record is kept both in printed and electronic forms. Ensure that accurate results are reported in a timely and appropriate manner.
- Evaluate and improve lab procedure in the lab.
- Performs out-of-specification (OOS) and out of trend (OOT) investigations.
- Communicate with other NAI departments about samples and projects status.
- Manage the qualification, validation and maintenance program for all lab equipment.
- Assists with laboratory equipment maintenance and calibration programs, including troubleshooting efforts.
- Provide technical leadership for instruments such as HPLC, GC, FTIR and ICP.
- Oversee the chemistry/microbiology inventory and supplies to support effective lab operations.
- Communicate with contractors regarding lab equipment and with vendors regarding specialty consumables.
Supervisory responsibilities:• Supervise the QC chemistry and microbiology staff to include hiring, training, scheduling, evaluating competency, mentoring, disciplining.
• Manage the training program for chemistry and microbiology analysts regarding laboratory procedures, analytical instruments and testing methodologies.
• Ensure that adequate and up-to-date training records are kept for lab analyst staff.
• Oversee a proficiency testing program to monitor the efficacy of the training program.
• Review analyst staff performance, address deficiencies and perform annual review assessments.
Safety responsibilities:• Maintain a safe, organized and clean work environment in the chemistry and microbiology lab.
• Assist in the management of NAI Chemical Control Program.
• Oversee the lab Chemical Hygiene Plan.
• Manage the lab hazardous material disposal program and support proper disposal of all NAI wastes.
• Assigns the QC representative to the Safety committee.
Quality responsibilities:• Maintain cGLP and cGMP standards and ensure that all NAI procedures and policies are followed within the chemistry and microbiology lab.
• Review and revise Standard Operating Procedures (SOP) and other quality documents.
• Participate actively in audits (internal and external) and in remedial actions for any non-compliance observations made in the chemistry lab.
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Other responsibilities:• Perform special projects as assigned by the QC Manager.
• Perform duties of the QC Manager in their absence.
QUALIFICATIONSEducation: BA/BS, MS or Ph.D. degree in chemistry or biochemistry.
Experience:• Minimum 6 years (BA/BS) or 4 years (MS) or 2 years (Ph.D.) of experience in a cGLP/cGMP lab is a must. Preferably in the dietary supplement, food or pharmaceutical industry.
• Minimum 2 years supervisory/leadership experience.
• Requires strong analytical and technical troubleshooting skills, especially with chromatography instrumentation such as HPLC. Ability to investigate and resolve chromatographic, physical and wet chemical issues and microbiological testing anomalies and investigations.
ADDITIONAL SKILLSDecision MakingDecisive, analytical, self-starter, excellent problem solving skills
CommunicationExcellent oral and written communication skills. Ability to communicate effectively with staff, other NAI departments, contract labs, clients, vendors, service technicians, etc. Ability to write quality reports, SOPs and other work related documents.
PlanningAbility to multi task and perform under stressful conditions
PHYSICAL DEMANDS• While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms; stoop and kneel; talk and hear. The employee is frequently required to sit and stand.
• Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and the ability to adjust and focus.
• Lifting requirement: Up to the maximum safety-recommended 50 pounds.
The physical demands are representative of those that must be met by employee to successfully perform the essential functions of this job. Reasonable accommodations may be made upon request to enable individuals with qualified disabilities to perform the essential functions of the job.
WORK ENVIRONMENTQC Lab with various analytical instruments and various lab equipment, chemicals and solvents where PPE is required (lab coat, gloves and protective glasses). Also, computer workstation and climate-controlled office environment. May occasionally enter production areas where PPE might be required to prevent or lessen exposure to airborne-borne powdered nutritional supplement substances and/or prevent manufacturing materials from contamination.
M-F 8:00am to 5:00pm
