QA Internal Auditor Sr. - Glidewell Laboratories

QA Internal Auditor – Sr.

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Position Reports To: Quality Assurance Manager

Position Directly Supervises: None

Job Division: RA/QA

Over-Time Status: EXEMPT

Purpose Of Position: The Internal Auditor will maintain and conduct the internal audit process. The team member is responsible for generating the audit schedule, conducting audits, analyzing audit results, and presenting findings. Must be capable of working within a team environment, striving to meet or exceed customer expectations, and committing to continuous improvements in quality.

To fulfill this position successfully, an individual must be able to perform each essential function satisfactorily.

Essential Functions:

  • Understand and follow Prismatik’s Quality Manangement System per training.
  • Understand and comply with rules and Company policies.
  • Manages the internal audit lifecycle including but not limited to planning, generating the audit schedule, execution, reporting, managing response, and follow-up on commitments/CAPA.
  • Conduct internal audits and participate in third party audits.
  • Review and monitor documentation, as assigned, to ensure compliance with relevant standards, regulations, and guidance documents.
  • Coordinate, liaise, and participate with internal teams to provide guidance on manufacturing processes or quality systems compliance.
  • Learn and understand relevant domestic and international standards and regulations in order to monitor and ensure conformance.
  • Analyze all elements of the Quality System and judge their degree of adherence to the criteria for management and control processes.
  • Collect and analyze data to evaluate department goals and objectives for the internal audit process.
  • Perform verification and effectiveness check of the action items implemented by process owner.
  • Maintain the Internal Audit database.
  • Participate in supplier audit as part of critical supplier selection and evaluation.
  • Interpret recommendations/observations/findings from the result of the audit to ensure that corrective actions are appropriate and effective.
  • Present and distribute internal audit reports including action items from internal audit results.
  • Participate in improvement projects for the Quality System, as needed
  • Performs other related duties and projects as business needs require at direction of management.

The preceding functions have been provided as examples of the type of work performed by employees assigned to this job classification. Management reserves the right to add, subtract, or change the job functions.

Minimum Qualifications: The requirements listed below are representative of the knowledge, skill, and ability necessary to successfully perform the essential functions of the position.

  1. Education and Experience:
  • Bachelor’s degree in related field or equivalent experience.
  • Minimum of 3 years of experience in quality systems within the medical device industry.
  • Minimum 4 years experience performing GMP/ISO internal audits.
  • Training in Quality Systems including relevant Regulations and Standards
  • Previous experience developing and adhering to Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Standard Operating Procedurs (SOPs).
  • Quality assurance experience in a manufacturing environment is a plus.
  • Previous technical writing experience a plus.
  • Previous experience in root cause analysis and corrective and preventive action methods.

Special Requirements/Certification:

  • ASQ Certified Quality Auditor, ASQ Certified Biomedical Auditor, ASQ Certified Medical Device Auditor OR IRCA Certification preferred
    • Must possess effective oral communication and interpersonal skills with ability to deal with all levels of personnel, professionally and effectively, in a multi-cultrual business environment
    • Must be able to effectively present material, confidently, to large and small groups
    • Must demonstrated active listening skills
    • Ability to create and compose professionally written documents
    • Ability to compose professionally written email correspondence

Communication Skills:

  • Act as a liason between internal audit and regulatory agencies, suppliers, and internal teams
  • Ability to interpret existing and emerging regulations, standards, or guidance documents including potential impact on regulatory and quality functions
  • Must be able to read and understand all operating procedures and applicable technical information
  • Ability to analyze and correct complex processes, using statistical techniques and independent judgement, when applicable, and present data regarding the QMS
  • Proficient English; comprehension, verbal and written communication skills, i.e.
  • Assertive and not afraid to ask questions
  • Friendly, good attitude, customer service oriented

Knowledge, Skills, and Abilities

  • General knowledge of office procedures.
  • Advanced skills in the MS Office suite (Excel, Word, and Outlook).
  • Demonstrated reliability, dependability and flexibility in work habits.
  • Demonstrated attention to detail and accuracy.
  • Demonstrated abilities to effectively coach and counsel others in a professional, non-threatening manner.
  • Ability to effectively prioritize and organize project tasks and goals effectively.
  • Ability to work with various supervisors, managers, and employees to ensure project goals are met.
  • Willing to seek guidance and accept feedback from RAQA Management, Directors and VPs
  • Ability to determine work procedures by observing tasks and interviewing informational resources.
  • Ability to work independently with minimal supervision and effectively contributes as a team player.
  • Demonstrated knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
  • Ability to travel, as required

Physical Demands: The physical demands listed below are representative of those that must be met by an employee to successfully perform the essential functions of this position.

§ Ability to frequently bend and/or twist at waist/knees/neck to and from seated position while working at desk/bench and reaching for equipment.

§ Ability to frequently use standard office equipment such as but not limited to computers, telephones, copiers, and scanners.

§ Ability to constantly communicate with others.

§ Ability to maintain long periods of mental alertness and attention to detail while setting priorities, meeting critical deadlines, and following up on assignments.

§ Ability to constantly perform sedentary work, spending extended periods of time at desk or workstation.

§ Ability to frequently stand and/or walk for extended periods of time.

§ Ability to seldom push and/or pull up to five (5) pounds.

§ Ability to seldom lift or carry up to five (5) pounds.

§ Ability to keyboard for extended periods of time.

§ Ability to function in an environment with frequent interruptions.

§ Ability to deliver quality results under high pressure deadlines in a fast-paced environment.

§ Ability to demonstrate manual dexterity and eye-hand coordination.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this position.

  • Primarily an office setting environment with moderate noise levels and no direct exposure to hazardous physical substances.