Quality Assurance Manager

Position Summary: The Quality Assurance Manager is responsible for the whole oversight of the Quality Assurance, and floor quality at both manufacturing and packaging sites. They are to appropriate, delegate, and review Quality Assurance operations and related tasks to ensure the company’s full Quality Assurance support as well as quality operational guidance and training to staff and other departments within the organization. They will need to ensure the quality assurance group is 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 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, Internal SOPs, training and 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, subsequent CAPA’s and/or any other such required instances.
• As necessary, thoroughly review completed and/or prepare 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 Assurance 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 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.
• Analyzes quality data and makes recommendations for improvement by participating in development, interpretation, and implementation of policies and procedures for the area of responsibility.
• Initiates 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.
• Manages all Captek sites on the use of electronic QMS systems (QCBD/Master Control)
• Adhere to HACCP and Food Safety.

Requirements:

• 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 interdepartmentally on matters pertaining to QA.
• Perform other related quality and compliance duties as assigned by Vice President of Quality, Regulatory Affairs and Technical Operations.
• Analytical competency - 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.
• Teamwork - Balances team and individual responsibilities.
• Accountability - Upholds own responsibilities while keeping others engaged with the task requested in cases of collaborative work.
• Judgment - Exhibits sound and accurate judgment; Supports and explains reasoning for decisions.
• Planning/Organizing - Prioritizes and plans work activities.
• Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
• Overseas plant sanitation programs to ensure sanitary standard operation procedures and regulatory requirements for food manufacturing.

Qualifications/Education/Experience:

• Minimum of 6 years relevant work experience with 4 years in a Supervisory and/or Managerial role
• Experience managing and scheduling a shift of five (5) or more employees is preferred.
• Experience in training personnel.
• Bachelor Degree in Health Science or related discipline is preferred.
• Deep working knowledge of cGMPs and FDA regulations.
• ASQ CMQ, PCQI and/or CHA certifications are preferred.

Work Environment:

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.

Physical Demands:

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 the 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.

Job Type: Full-time

Pay: $80,000.00 - $110,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• 10 hour shift
• 8 hour shift

Application Question(s):

• Do you have experience and working knowledge of cGMPs and FDA regulations?
• Do you have experience in FDA regulated food production or nutraceutical environments?

Experience:

• Supervising: 4 years (Preferred)
• Schedule management: 1 year (Preferred)
• Quality Management: 4 years (Required)

License/Certification:

• ASQC Certification (Preferred)

Ability to Relocate:

• Vista, CA 92081: Relocate before starting work (Required)

Work Location: In person