Quality Assurance Auditor
Location : Lancaster, SC
Job Type : Direct
Reference Code : CRC_QAA
Hours : Full Time
Required Years of Experience : 5+
Required Education : Not specified
Travel : No
Relocation : No
Industry : Pharmaceutical
Job Description :
- Reputable manufacturer of specialty health products who are industry leaders in setting and adhering to high standards in manufacturing and quality control
- Company focuses on researching and developing products to promote consumer health and is highly regarded in the industry for their advancements in the medical space
SCOPE OF THE ROLE:
- This role is responsible for developing and maintaining a strong Internal Compliance program ensuring compliance to applicable regulations. The QAA is also required to support external audits as needed. The QAA must prioritize schedule of audits and have oversight for corrective actions to the findings identified.
- Manage audit planning, scheduling, and execute internal audits in all facilities to assess compliance to the regulations.
- Function as a backup as well as support the efforts of Supplier Quality Engineer.
- 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.
- Assist internal departments so that they are able to understand and comply with Quality and Compliance expectations.
- Assessing the 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 Quality Assurance teams.
- Report audit metrics to Quality Assurance and department management.
- Performance of other duties may be required for meeting compliance requirements.
Required Qualifications :
- B.A or B.S in Science or Technical Field preferred, but not required
- Knowledge of the Regulations 21 CFR 507 as well as the Dietary Supplement Regulations 21 CFR 111.
- Must have a minimum of 5years of experience in Quality Assurance including Supplier Quality Management.
- ASQ Certified Auditor (CQA) Certification is preferred
- Experience auditing for compliance
- Strong knowledge of GMP manufacturing regulations
- Must be proficient in MS office suite
- Must be able to effectively communicate with other departments and function within a team environment
- Must be able to stand or walk for long periods, as well as be able to walk outdoors on potentially uneven surfaces to assess facility exteriors
- Must be able to travel for audits as needed by the company