QC Supervisor, Chemistry

Natural Alternatives International, Inc.; Vista (CA); On-site; USD 95,000 - 125,000; Full time

Job summary

Natural Alternatives International, Inc. is seeking a QC Lab Supervisor to lead the QC chemistry and microbiology teams, ensuring all activities comply with cGLP/cGMP and NAI policies.

Under the guidance of the QC Manager, you will plan, organize, and evaluate routine and non-routine testing in support of operations, production, R&D, and QA. Responsibilities include training staff in cGMPs and SOPs, writing and revising SOPs, managing OOS/OOT investigations, supervising analysts, and providing

Qualifications

• Requires 6+ years in a cGLP/cGMP lab; supervisory experience preferred.
• Experience with chromatography instrumentation (HPLC) and troubleshooting.
• Develops and revises SOPs; supports audits and continuous improvement.
• Strong analytical and technical problem-solving skills; effective communicator.

Responsibilities

• Plan and direct routine and non-routine QC activities in chemistry and microbiology.
• Provide technical leadership for HPLC, GC, FTIR, ICP.
• Maintain cGLP/cGMP compliance and quality documents (SOPs, records).
• Oversee training and SOP program; manage OOS/OOT investigations.
• Supervise staff; perform annual reviews and maintain records.

Skills

cGMP compliance

SOP development

Leadership

HPLC

Chromatography troubleshooting

Analytical methods

Technical reporting

Written communication

Education

BA/BS, MS or PhD in chemistry/biochemistry

Tools

HPLC

GC

FTIR

ICP

Job description

Under 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

• 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-daylaboratory operations to ensure that production and R&D needs are met.
• Plan the daily and weekly work assignments of the chemistryand microbiologyanalysts.
• 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 theQC 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.

SUMMARY

Under 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.

OTHER RESPONSIBILITIES

• Perform special projects as assigned by the QC Manager.
• Perform duties of the QC Manager in their absence.

QUALIFICATIONS

EDUCATION

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 SKILLS

DECISION MAKING

Decisive, analytical, self-starter, excellent problem solving skills

COMMUNICATION

Excellent 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.

PLANNING

Ability 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 disabilitiesto perform the essential functions of the job.

WORK ENVIRONMENT

QC 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.

NAI is an affirmative action/Equal Opportunity Employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, physical or mental disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.