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Quality Assurance Manager

4 months ago

Vista, United States CAPTEK® Softgel International Full time

Summary: 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 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, subsequent CAPA’s 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.
  • Manages all Captek sites on the use of electronic QMS systems (QCB/MasterControl).
  • Adhere to HACCP and Food Safety.
  • 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 Vice President of Quality, Regulatory Affairs & Technical Services.


Qualifications:

  • 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.


Education/Experience:

  • 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, PCQI and/or CHA certification 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.


EEOC Statement:

CAPTEK is an equal employment opportunity employer. In order to provide equal opportunities to all individuals, employment decisions will be based on merit, qualifications, and abilities, not on any mental or physical disability. We comply with the law regarding reasonable accommodation for disabled employees and applicants.

We do not discriminate on the basis of actual or perceived race, color, national origin, ancestry, sex (which includes pregnancy, childbirth, breastfeeding and medical conditions related to pregnancy, childbirth or breastfeeding), reproductive health decisions, gender, gender identity, gender expression, religious creed, disability (mental and physical) including HIV and AIDS, medical condition (cancer and genetic characteristics ), genetic information, age, marital status, sexual orientation, military and veteran status, or any other characteristic protected by federal, state or local law. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment.