Job Description
Title : Auditor/ Internal Compliance and Quality Assurance Audit Manager
Duration : fulltime role - Direct hire
Location : Lancaster South Carolina 29720
Salary : $65,000 to $90,000/annually + 15% annual bonus
Benefits : Medical insurance/ Vision insurance/ Dental insurance/ Tuition assistance/ Disability insurance/ Childcare support/ 401(k)
Summary of the Position
- The Quality Assurance Auditor reports to the Director of Quality. This role is responsible for developing and maintaining a strong Internal Compliance program ensuring compliance to applicable regulations.
- The QAA is required to perform internal and external audits, prioritize audit schedules and corrective actions to the findings identified.
Roles and Responsibilities
- Manage audit planning, scheduling, and execute internal and external audits for South Carolina and Maryland Facilities to assess compliance to the regulations.
- Audit external suppliers (CMO's) and maintain the vendor qualification program including the Approved Vendor List.
- Determine the level of risk of findings identified and follow up on corrective actions ensuring they address the short-term correction as well as the preventive action of the finding.
- Develop and implement a performance tracking system and reporting of departmental compliance.
- Prioritize work to ensure that audits and reports are completed in a timely manner. Support implementation of CAPA program where necessary.
- Train and assist internal departments to understand and comply with Quality and Compliance expectations.
- Assess internal audit process by identifying and prioritizing areas of the business where there is a risk of non-compliance and assist in development and/or execute processes or policies to reduce that risk.
- Support training and readiness for regulatory inspections.
- Provide support to the South Carolina and Maryland Quality Assurance team.
- Report audit metrics to Quality Assurance and department management.
- Communicate effectively with all levels of the organization and departments within the organization and function within a team environment.
- Understand the roles and responsibilities of the Contract Manufacturing Organizations and provide Quality Assurance support.
- Review and Release CMO batch records and assist with in house batch release as needed.
- Familiar with QA functions in SAP.
- Perform other assigned duties as may be required in meeting Quality Assurance and company objectives.
- Manage external vendor responsible for international audits.
- Manage the client supplier corrective action request program (SCAR).
Minimum Requirements
- Must have a minimum of 5 years of Quality Assurance auditing experience in cGMP environment with a minimum of 5 years of external vendor/ supplier compliance auditing experience within an FDA regulated industry or 10 years of related Quality Assurance experience in a GMP environment. Direct experience in pharmaceutical, food, or medical device industry.
- Knowledge of the Regulations 21CFR Part(s) 210, 211, 507 as well as the Dietary Supplement Regulations 21 CFR 111 is required.
- ASQ Certified Auditor (CQA) Certification is required.
- Must be proficient in MS office suite.
- Must be able to stand, walk, push, and pull in a variety of environments including a Manufacturing and clean rooms. Must have the ability to wear all required Personal Protective Equipment (PPE) based on the auditing environment. Must be able to travel 20 - 30% for domestic audits, (International travel may be needed per quality management).
Education and Experience:
- B.A. or B.S. in Science or Technical field required.
Note: If interested please email me your resume at anil.chamoli@mastechdigital.com or call me at T: +1 617.848.2285 | C:+1 973.922.1844.
Best Regards,
Anil Chamoli
Team Lead ( Recruitment & Sales)
T: +1 617.848.2285 | C:+1 973.922.1844
Anil.Chamoli@mastechdigital.com
Job Tags
Full time, Contract work, Temporary work,