Quality Operations Supervisor (58018)

About the role

The Quality Operations Supervisor will ensure that all Quality related functions are compliant with GMP regulations and consistent with company policies and procedures in addition to conducting audits that insure continuous control over materials, facilities and products throughout the production cycle.

Supervisory duties

• Performs a variety of leadership duties and job tasks within assigned department and/or work area, ensuring that all applicable safety laws/regulations, as well as state/federal employment laws that pertain to position are followed in accordance with Company policies, procedures, standards, and work-rules.
• Supports Company policies, procedures, and work-rules and ensures that department employees comply with policies, standards, and work-rules.
• Assists with interviewing and selection process of new hires for department, ensuring that non-discriminatory laws and guidelines are followed.
• Provides coaching, guidance, and training to department employees; ensures that employee meets company standards and work expectations as required by job description.
• Reviews safety rules with new department employees, ensuring that Company safety policies and work rules, as well as machinery safety rules and guidelines are understood, before the worker is allowed to operate machinery independently; participates in injury/accident investigations, and completes necessary reports; conducts daily safety inspections of machinery and work area.
• Counsels and disciplines employees, as needed, to ensure compliance with Company policies, standards, and work rules.
• Sets a positive example of leadership to others within the department and throughout the organization; promotes a leadership style that encourages open communication, positive team-building efforts and employee morale.
• Completes 90-Day and annual employee performance evaluations for all department employees.
• Participates in employee suspension and termination meetings.
• Performs other supervisory and managerial duties as needed/requested by senior management.

Essential job duties and responsibilities

• Monitor manufacturing activities to ensure compliance with approved procedures, batch record instructions, in-process controls, product specifications, and company procedures, approved specifications, and quality standards.
• Supervise, train, coach, and provide technical guidance to Quality Operations personnel; assign daily responsibilities, monitor performance, and ensure consistent execution of quality requirements and departmental objectives.
• Coordinate with Manufacturing, QC, Warehouse, and other cross-functional teams to investigate and resolve quality issues, improve manufacturing processes, and support continuous improvement initiatives.
• Review and approve batch production records, in-process documentation, and related quality records to ensure accuracy, completeness, and compliance with established requirements.
• Support finished product disposition and release decisions through review of batch production records, laboratory test results, in-process control results, deviation investigations, and compliance with approved specifications and cGMP requirements.
• Lead and oversee investigations related to manufacturing deviations, nonconformances, customer complaints, and other product quality issues, including root cause analysis, product impact assessment, corrective actions, and effectiveness verification.
• Monitor quality performance indicators, including process performance, customer complaint trends, nonconformance trends, and other manufacturing quality metrics; communicate significant quality issues and improvement opportunities to management.
• Work closely with QC Laboratory and other relevant departments to coordinate the disposition of raw materials, in-process materials, and finished products.
• Review, maintain, and update Quality Operations procedures, work instructions, and related quality documentation to ensure they remain current, effective, and compliant with applicable requirements.
• Provide quality and GMP training support to Quality Operations personnel and manufacturing teams to promote consistent implementation of quality practices.
• Lead or participate in quality improvement projects, cross-functional initiatives, and process optimization activities as assigned by management.
• Support customer audits, certification body audits, and regulatory inspections related to manufacturing operations, including preparation of quality documentation, audit responses, and follow-up actions.
• Comply with all company policies and procedures, including safety rules and regulations; maintain a safe working environment and perform duties in accordance with established safety requirements.
• Perform other job-related duties as assigned by management.

Qualifications

The requirements listed below are representative of the knowledge, skills, education, and/or abilities required for the job:

• Knowledge of GMP, CFR & other Regulatory Compliance; In-depth understanding and working knowledge of FDA and cGMP regulations.
• Should have a knowledge and understanding of quality in the manufacturing environment.
• Should have the ability to work at a fast pace, work with interruptions, and deal effectively with confidential information.
• Ability to work with a diverse cultural environment.
• Detailed oriented, patient, and thorough.
• Strong interpersonal skills for routine interactions with management.
• Experienced at providing verbal and written reports.
• Proficient skills in reading, writing, and speaking in English; bilingual skills a plus.
• Excellent written and oral communications skills & techniques.
• Effective planning & organizing skills; ability to handle multiple task/duties.
• Proficient with Microsoft Office Products.
• Effective problem-solving skills.
• Ability to work independently and in a team environment.
• Ability to maintain a positive, professional, cooperative demeanor, conduct, and working relationship with peers, management, employees, and other individuals that interact with this position.
• Ability to comply, interpret and support Company policies, procedures, work rules, and protocols.
• Ability to adapt effectively to workplace changes and new job duties/responsibilities.
• Ability to represent the Company in a positive and professional manner at all times.

Required education and experience

• BA/BS in Science or related with at least 5 years nutritional and/or related industry in a quality management role or an advanced degree with +2 year of experience.
• Experience working in a manufacturing environment.
• Experience working in a fast-paced work environment.
• Any combination of experience, education, and training that provides the level of knowledge, skills, and experience needed to successfully perform the job.

Skills

• Solid operating skills including timely decisions, managing and measuring work along with good overall time and project management.
• Proficient in Word, Excel and PowerPoint with the ability to promptly learn and master regulatory/compliance software.
• Experience in electronic enterprise quality management and documentation systems are a plus.
• Demonstrate strong technical ability and skills in assigned work area to include product, process and/or testing knowledge.
• Ability to understand and set priorities and workload and to establish collaborative relationship with peers.
• Strong interpersonal skills to positively and professionally interact with colleagues and work in a team-oriented environment.
• The ability to prepare and present reports to management pertaining to non-conformances.
• Ability to multitask and handle a heavy volume of work.
• Ability to work independently and under pressure.
• Strong verbal and written communication skills.
• Ability to work with a high degree of accuracy and detail.

Physical demands and working conditions

The essential functions of this job require the employee to perform the following physical activities during the course of work:

• Communicates orally with management, employees, co-workers, vendors, suppliers, governmental compliance agencies, and the public by telephone or in person, in one-on-one or group settings.
• Regularly uses a telephone, computer (e-mail) for communication.
• Required to stand, walk, and sit for extended periods of time during work shifts.
• Routinely required to stoop, bend, kneel, lift, reach, pull, push, and tilt object in the performance of job function.
• Requires the essential use of hands, speech, eyesight, and hearing.
• Lifting limitations for this position: 25-30 lbs. May have to manipulate heavier containers.
• Vision requirements include close and distance vision, color vision, peripheral and depth vision, and the ability to adjust focus as needed.
• Requires incumbent to sit and operate computer for extended periods of time during course of workday, and the ability to proficiently use the computer keyboard for typing.
• Noise levels for most work environments can range from low to moderate. Some work areas require hearing protection for an 8-hour workday.
• Periods of odoriferous environment.
• Work may involve moderate exposure to unusual elements, such as extreme temperatures, dirt, dust, fumes, unpleasant odors, and/or loud noises. Personal Protective Equipment provided as necessary.
• Work environment may involve exposure to chemicals, solutions, detergents, or solvents that require following extensive safety precautions and may include the use of personal protective equipment.
• Work environment may involve exposure to allergens such as Soy, Wheat, Fish, Shell Fish, Milk, Egg, Tree nuts, and Sesame.