QA Complaint Data Specialist
Job Code: #567
Job Type: Contract
Salary: $19.00 - $21.00/hour
Job Location: Wilson, NC
Job Description Job Title: Quality Compliance Specialist
Pay: $19.00 - $21.00/hour
POSITION SUMMARY: The QA Compliance Specialist works with the Compliance Management Team to Identify and correct cGMP inadequacies at the Production Unit, as well as, helping to develop and implement Quality Systems designed to maintain a high level of internal and external audit readiness and Regulatory Compliance. The position is responsible for facilitating the approval of the Annual Product Quality Review (APQR) and the development of relevant systems designed to maintain compliance with the various APQR procedures and Regulatory Agency requirements. The QA Compliance Specialist participates in compliance initiatives based on new regulations, guidance documents and industry standards and applies them to the six systems when directed. The position will also provide support for event initiation, investigations, and internal audits.
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT:
• Participates in multi-functional project teams as a Compliance representative as directed by the Compliance Management Team
• Responsible for compiling, processing and facilitating the Annual Product Quality Review in a timely manner
• Assists in ensuring adherence to regulatory requirements and industry guidance through the review of appropriate documentation and internal audit activities as directed by the Compliance Management team
• Responsible for the compliance of the storage and archiving of documents with company policy and Regulatory Agency requirements
• Assists and coordinates compliance initiatives based on new regulations, guidance documents and industry standards as they apply to site Quality Assurance
• Participate in FDA readiness audits as required by the Compliance Management team
• Performs other duties as assigned by Compliance Supervisor, Manager, or Director of Quality Assurance
• Bachelor’s degree in the sciences (or equivalent work experience) with a minimum of 1 to 3 years’ experience in pharmaceutical or related industry.
• Must have an in-depth knowledge of current GMP as well as FDA trends and guidelines.
• Must possess good communication skills, developed problem resolution and critical thinking skills.