QC Supervisor, Chemistry

Natural Alternatives International•Vista, CA

1d•Onsite

About The Position

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.

Requirements

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.
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.
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 to write quality reports, SOPs and other work related documents.
Ability to multi task and perform under stressful conditions

Nice To Haves

Preferably in the dietary supplement, food or pharmaceutical industry.
Experience with Empower and Mass Lynx software preferred.

Responsibilities

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.