The Quality Assurance Associate will assist in completing the day to day responsibilities of the Quality Assurance Manager. The Quality Assurance Associates will be trained and qualified to perform the job responsibilities for the area to which they are assigned, i.e., OTC drug product, medical device, dietary supplements, or cosmetics, and may be cross-trained, as needed. Responsibilities include, but are not limited to, reviewing applicable documentation to approve or reject product lots, review of significant deviations, qualification and oversight of contracted facilities, the external audit program, quality agreements, review and maintenance of product and/or purchasing specifications, verification of appropriate warehousing and distribution practices, and other GMP quality functions such as preparing or revising standard operating procedures, training materials, and change controls, as needed.
Principal Duties & Responsibilities
- Reviews Certificates of Analysis, Certificates of Compliance, product specifications, other documentation for completeness and correctness as per applicable procedures to approve or reject product lots. Completes and maintains appropriate documentation to support the disposition of product lots.
- Completes 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 the Family Dollar SOP.
- Communicates with the contract facility management as necessary to ensure the timely completion of required activities.
- Reviews finished product and/or purchasing specifications against applicable standards to confirm conformance with regulatory requirements.
- Assists in the vendor/supplier qualification program, including but not necessarily limited to performing audits or overseeing audits performed by third parties, developing an external audit schedule, assisting in the development of quality agreements and tracking status of quality agreements, and maintaining an Approved Supplier List.
- Assures that appropriate process validation and stability studies are conducted, and retain samples are maintained to support Family Dollar private-label products.
- Verifies that appropriate procedures are being followed by transportation companies, including but not limited to appropriate chain-of-custody and transportation conditions.
- Verifies that appropriate procedures are being followed by warehouse facilities, including but not limited to appropriate storage conditions, pest control, handling of returns, and waste disposal.
- Writes, reviews, and revises standard operating procedures and forms as necessary.
- Writes, reviews, and revises technical and quality system documents such as Change Controls and Deviation Reports, as needed.
- Notifies management of significant quality or compliance issues.
- Assists the Quality Systems group with data collection for, and preparation of, metrics, Quality Council meeting materials, and Annual Product Reviews, as needed.
- Assists in other functions in the department, as needed.
- Review and maintenance of product labels/labeling control
- Proficient with Microsoft office applications.
- Strong attention to detail.
- Excellent verbal and written communication skills with the ability to interact with contract facility management.
- Ability to work independently guided by documented procedures, with appropriate support.
- Able to work effectively as part of a team.
- 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.
- Bachelor of Science degree in a science or engineering discipline.
- Minimum 3 years of Quality Assurance work experience in FDA regulated industries (pharmaceutical or medical device industry preferred).
- Working knowledge of FDA Quality Systems (cGMP) and regulatory requirements (21CFR, Parts 111, 210, 211, 700 and 820).
- Thorough understanding of Good Documentation Practices.
Start Rate = $60,610 to $78,780 based on experience