Quality Assurance & Regulatory Manager is responsible for the whole oversight of the Quality Assurance department, and floor quality at both manufacturing and packaging sites. They are to appropriate, delegate, and review Quality Assurance operations and related tasks to ensure company’s full Quality Assurance support as well as quality operational guidance and training to subordinate staff and other departments within the organization. They will need to ensure the quality assurance group in properly evaluating floor process quality systems and controls, investigations and dispositions, and any other quality needs to drive to quality product manufacture, processes, and systems. The individual will need to continually review and uphold company policies, procedures, and quality requirements required in the dietary supplement industry.
Essential Duties and Responsibilities:
- Manages all QA Supervisors, Assistant Supervisors, Leads, Technicians, and Document Control Specialists in both manufacturing and packaging facilities. This may include, but is not limited to, scheduling and coordinating work assignments for the department/shifts, along with planning and setting QA department goals and objectives, and respectively coordinating and directing QA department activities.
- Per compliance to cGMP, Captek SOPs, and training, thoroughly reviews and verifies Quality Assurance systems and operations within the department and in application at floor, driving facilities’ organizational quality.
- Conduct departmental adherence, task, and/or job performance reviews which include developing and managing metrics to track and drive facilities’ quality performance, respective appropriate actions for negative trend remediation, and for continual improvement.
- Represents Captek’s Quality Assurance operations as needed in customer and regulatory audits, meetings, qualifications, and/or any other such required instances.
- As necessary, thoroughly reviews completed and/or prepared Quality Assurance documentation and dispositions or endorses appropriately upon verification of documentation as accurate, true, and complete.
- Authors and/or reviews Quality Assurance related SOPS, while ensuring proper adherence to by subordinate Quality Control staff.
- Perform and/or coordinate training of department personnel as needed, while developing, interpreting, and implementing policies and procedures for the area of responsibility.
- Leads cross-functional teams on projects as pertaining to quality and process control initiatives, investigations, policies and/or procedures writing/review, best practices, and/or corrective and preventative action plans.
- Assist QA Supervisors for interviewing and hiring QA personnel
- Analyze quality data and make recommendations for improvement, participating in development, interpretation, and implementation of policies and procedures for the area of responsibility
- Initiate disciplinary actions and investigates incidents when required, as appropriate
- Maintains a strong conceptual understanding of the processes, procedures, and quality requirements required of our operations. Provides staff with respective guidance and support.
- Assures facilities’ compliance with quality requirements, exemplifying adherence to all safety, cGMP, and Captek’s Standard Operating Procedures and Policies, particularly, while keeping accountability of staff to the same.
- Must have the ability to be flexible, handle and support multiple projects simultaneously and adjust personal style to adapt to increased business pressures and work well under pressure while performing all tasks in an accurate, complete, timely and appropriate manner.
- Must have the ability to communicate effectively inter- and intra- departmentally on matters as pertaining to QA.
- Perform other related quality and compliance duties as assigned VP of Q&R.
- Minimum of 10 years relevant work experience with 5 years in a Supervisory and/or Managerial role.
- Experience managing and scheduling a shift of five (5) or more employees
- Experience in training personnel
- Minimum Bachelor’s degree in health science or related discipline. Master’s degree preferred. Equivalent combination of education, experience, background, and assessed aptitude and capacity
- Deep working knowledge of cGMPs and FDA regulations
- ASQ CQA and/or CHA certification preferred
- The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles and risk of electrical shock.
- The noise level in the work environment is usually moderate.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Physical demands require sitting for extended periods of time, walking, bending, reaching, carrying, and occasionally lifting and/or moving objects up to 25 pounds. Specific vision abilities required by this job include Close vision, Peripheral vision and Ability to adjust focus. While performing the duties of this job, the employee is occasionally required to use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear.
To perform the job successfully, an individual should demonstrate the following competencies:
- Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data. Demonstrates attention to detail.
- Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
- Technical Skills – Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
- Interpersonal – Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others’ ideas and tries new things.
- Oral Communication – Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Participates in meetings.
- Team Work – Balances team and individual responsibilities; Exhibits objectivity and openness to others’ views; Gives and welcomes feedback; Contributes to building a positive team spirit; Supports everyone’s efforts to succeed; Recognizes accomplishments of other team members.
- Written Communication – Writes clearly and informatively; Edits work for spelling and grammar; Presents numerical data effectively and accurately; Able to read and interpret written information.
- Quality Management – Demonstrates accuracy and thoroughness.
- Diversity – Shows respect and sensitivity for cultural differences; Promotes a harassment-free environment.
- Ethics – Treats people with respect; Upholds organizational values.
- Support – Follows policies and procedures; Supports organization’s goals and values.
- Adaptability – Adapts to changes in the work environment; Able to deal with frequent change, delays, or unexpected events.
- Attendance/Punctuality – Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
- Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals.
- Accountability – Upholds own responsibilities while keeping others engaged with the task requested in cases of collaborative work.
- Initiative – Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Asks for and offers help when needed.
- Judgment – Exhibits sound and accurate judgment; Supports and explains reasoning for decisions.
- Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Keeps area organized and structured so as to adequately manage tasks
- Professionalism – Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
- Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
- Quantity – Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
- Safety and Security – Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
- To Apply:
If you are interested in this position, please send résumé to Theresa