The Quality Operation Manager 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.
ESSENTIAL JOB DUTIES / RESPONSIBILTIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactory. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the
Essential job functions. Essential job functions and duties include, but are not limited to:
Evaluate quality systems, processes, procedures and protocols for compliance.
Work with other management in the development and maintenance of quality management systems.
Work with senior management to track Quality performance to key performance indicators (KPI).
Coordinate with manufacturing to resolve quality issues and drive quality improvement throughout the facility.
Perform trending on Quality System; provide evaluation to Senior Management.
Lead, participate in, and provide leadership for projects designated by upper management.
Recognize trends, deviations, problems and promptly report them to management.
Write and review of Standard Operation Procedures and Quality Operational Procedures.
Perform trend analysis to monitor process, customer complaints and other quality parameters.
Conduct investigations and root cause analysis to identify root causes for problems and complaints.
Recommend and implement corrective action to prevent recurrence in collaboration with Quality Systems.
Perform Internal Quality Audits and provide support to senior management in handling audits by external auditing agencies.
Maintain a working knowledge of government and industry Quality standards.
Work closely with the QC lab to coordinate the disposition of raw materials & products.
Ensures through subordinates that the CAPA system are effective and that CAPAs are monitored for timely close out.
Monitor Non-Compliance reports and take corrective actions to assure timely completion;
Ensure the labels for drug and/or nutritional product are in compliance.
Conduct in-house cGMP training and awareness programs for Quality Operation staff and other employees as needed.
Ensure manufacturing of the products are executed as per cGMP guidelines and Best Formulations written Standard Operation Procedures.
Complies with all Company policies and procedures, including safety rules and regulations.
Maintains a safe work environment and operates in a safe manner.
Perform other related job duties as assigned by management.
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, 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.
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 work load 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 multi task 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.
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;
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;
In-depth understanding and working knowledge of FDA and pharmaceutical cGMP regulations.
Must have the ability to be flexible and proactive; able to practice good prioritization; maximize efficiency; and have good organizational skills;
Must be willing to work late or weekends, if needed;
Must have 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;
Excellent written and oral communications skills & techniques;
Effective planning & organizing skills; ability to handle multiple task/duties;
Proficient PC skills (Microsoft Word, Excel, Powerpoint);
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.
The appropriate knowledge, skills and abilities required for this position are achievable through the following combination of education, work experience and training:
BA/BS in Science or related with at least 5 years pharmaceutical, 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; or
Any combination of experience, education, and training that provides the level of knowledge, skills, and experience needed to successful perform the job.
PHYSICAL DEMANDS & 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 general public by telephone or in person, in one-on-one or group settings.
Regularly uses a telephone, computer (e-mail) and fax for communication.
Required to stand, walk, and sit for extended periods of time during the course of work shift.
Routinely required to stoop, bend, kneel, lift, and reach, in the performance of job function.
Requires the essential use of hands, speech, eyesight, and hearing.
Lifting limitations for this position: 25-30 lbs.
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 work day, and the ability to proficiently use the computer key-board for typing.
Noise level for this work environment is typically low to moderate.
Note: The Company reserves the right to modify, update, change and/or make corrections to this job description, at the sole discretion of senior management, at any time during the employee’s employment term, at the sole discretion of management.