QC Supervisor, Chemistry

Summary

• Responsible for planning, organizing, directing, and evaluating routine and non-routine activities of the QC chemistry staff in support of operations, planning, production, R&D, QA and in full compliance with cGLP/cGMP regulations and NAI policies.

• Ensures all 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 chemistry laboratory operations to ensure that production and R&D needs are met.
• Plan the daily and weekly work assignments of the chemistry analysts.
• Collaborate with the lab administrative team and the director 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 procedures.
• 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 chemistry lab equipment.
• Assists with laboratory equipment maintenance and calibration programs, including troubleshooting efforts.
• Provide technical leadership for instruments such as HPLC, HPTLC, UPLC/MS, etc.
• Oversee the chemistry inventory to support effective lab operations.
• Communicate with contractors regarding lab equipment and with vendors regarding specialty consumables.

• Supervise the QC chemistry staff to include hiring, training, scheduling, evaluating competency, mentoring, disciplining.
• Manage the training program for chemistry analysts regarding laboratory procedures, analytical instruments and testing methodologies.
• Ensure that adequate and up-to-date training records are kept for lab staff.
• Oversee a proficiency testing program to monitor the efficacy of the training program.
• Review staff performance, address deficiencies and perform annual review assessments.

• Maintain a safe, organized and clean work environment in the chemistry lab.
• Assist in the management of NAI Chemical Control Program.
• Oversee the lab Chemical Hygiene Plan.
• Manage the lab hazardous material disposal program and oversee the proper disposal of all NAI wastes.
• Maintain an up-to-date inventory of hazardous materials with regulatory agencies.
• May act as a QC representative to the Safety committee.

• Maintain cGLP and cGMP standards and ensure that all NAI procedures and policies are followed within the chemistry Lab
• Review and revise Standard Operating Procedures (SOP) and other QC documents.
• Participate actively in audits (internal and external) and in remedial actions for any non-compliance observations made in the chemistry lab.

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

• Education:
  
  BA/BS, MS or Ph.D. degree in chemistry, biochemistry, or related field.

• Minimum 6 years (BA/BS) or 4 years (MS) or 2 years (Ph.D.) of analytical chemistry 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.
• Experience with Empower and Mass Lynx software preferred.

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

• Excellent oral and written communication skills. Ability to communicate effectively with staff, other NAI departments, contract labs, clients, vendors, service technicians, etc. Ability…