MINIMUM REQUIREMENTS/QUALIFICATIONS:

• Ability to work independently guided by documented procedures, with appropriate support.
• Able to work effectively as part of a team.
• Strong attention to detail.
• Excellent verbal and written communication skills with the ability to interact across function, departments, seniority levels and contract facility management.
• Ability to explain problems, develop solutions, and make recommendations, and the ability to handle various urgent requests in a professional manner.
• Effective time management and interpersonal skills.
• Ability to deliver within established timelines.
• Proficient with Microsoft Office applications.

PREFERRED QUALIFICATIONS:

• Bachelor of Science degree in a science or engineering discipline.
• Minimum 3 years of Quality work experience in FDA regulated industries. (pharmaceutical or medical device industry preferred).
• Working knowledge of FDA Quality Systems (cGMP) and regulatory requirements (e.g., 21 CFR Parts 111, 210, 211, 700 and 820).
• Thorough understanding of Good Documentation Practices
  Full time
  510 Volvo Parkway,Chesapeake,Virginia 23320
  Compliance
  Family Dolla

• Review Certificates of Analysis, Certificates of Compliance, product specifications, and other documentation for completeness and correctness as per applicable procedures to approve or reject product lots. Complete and maintain appropriate documentation to support the disposition of product lots.
• Complete a review of significant Deviation Investigations received from contract facilities, as defined in the Quality Agreement, to confirm that they meet the minimum requirements defined in Company SOPs.
• Communicate with contract facility management as necessary to ensure the timely completion of required activities.
• Review finished product and/or purchasing specifications against applicable standards to confirm conformance with regulatory requirements.
• Assist in the vendor/supplier qualification program, including but not limited to performing audits or overseeing audits performed by third parties, developing an external audit schedule, assisting in the development of quality agreements, tracking the status of quality agreements, and maintaining an Approved Supplier List.
• Assure that appropriate process validation and stability studies are conducted and retain samples are maintained to support Company private-label products.
• Verify that transportation companies are following appropriate procedures, including but not limited to appropriate chain-of-custody and transportation conditions.
• Verify that warehouse facilities are following appropriate procedures, including but not limited to appropriate storage conditions, pest control, handling of returns, and waste disposal.
• Write, review, and revise standard operating procedures and forms, as necessary.
• Write, review, and revise technical and quality system documents such as Change Controls and Deviation Reports, as needed.
• Notify management of significant quality or compliance issues.
• Assist the Quality Systems group with data collection for, and preparation of, metrics, Quality Council meeting materials, and Annual Product Reviews, as needed.
• Assist in other functions, as needed