Quality Assurance Associate

Job Description

The Quality Assurance Associate will assist in completing the day to day responsibilities of the various area managers to which they report. Quality Assurance Associates may be assigned to the Senior Quality Assurance Manager, Senior Quality Assurance Manager - Compliance, Quality Assurance Manager - Quality Systems, Quality Assurance Manager - Document Control, or the Senior / Quality Assurance Manager - Supplier Quality. Quality Assurance Associates will be trained and qualified to perform the following responsibilities depending on the area to which they are assigned.

Key Responsibilities/Essential Functions (as applicable)

• Inspect incoming raw materials and components according to established sampling plans.
• Perform in-process and finished goods product inspections of pharmaceutical products.
• Perform line clearance activities.
• Review third-party production records for compliance with good documentation practices, cGMPs, and to identify deviations from procedures and ensure products meet quality standards.
• Review and approve product production records and authorize product release.
• Assure the appropriate usage, disposition, and destruction of unused packaging components, including cartons, labels, and inserts.
• Initiate raw material and product deviations and assist with investigations as needed.
• Assemble data for the APR and prepare APR reports as applicable.
• Review production logs and environmental monitoring records.
• Monitor equipment calibration and preventive maintenance due dates.
• Work with Management to develop effective quality assurance procedures.
• Provide data and assist with FARs, Recalls and customer complaints.
• Prepare metrics and trending reports for Quality Council presentations.
• Maintain vendor quality agreements and the approved supplier list.
• Record and monitor consumer complaints in MasterControl.
• Assist in conducting complaint investigations and writing complaint investigation reports.
• Participate in Internal Audits as required.
• Create and maintain the master documentation files.
• Distribute and notify departments of document releases, changes. obsolescence of documents and reconcile controlled copies of documents.
• Review documentation prior to issuance to ensure compliance with site SOP's.
• Assist in the creation and updating of Standard Operating Procedures and forms specific to the document control processes.
• Conduct periodic reviews of the record retention system.
• Initiate Change Controls and assist in the Change Control process.
• Issue change control numbers, update electronic logs, route documents for review/approval and schedule change control meetings as required.
• Enter employee training in MasterControl, identify overdue training, implement training profile updates, and schedule training as required.
• Maintain/file physical GMP training records for personnel.
• Triage and initiate investigation requests with both internal team and external suppliers.
• Notify Senior Management of complaints with significant quality or compliance issues that might require a Field Alert/Recall according to the Management Notification SOP.
• Track closure of complaint investigations and associated CAPA's that may be generated at the Product Owner or contract facility sites as a result of the complaint.

• Contact complainant, as warranted, to obtain complaint samples for evaluation/testing or for additional information to conduct investigations.
• Ensure the proper storage of complaint samples at both the Product Owner and contracted facilities.
• Assist in developing and publishing the Supplier Audit Schedule, and tracking of audits.
• Maintain the Approved Vendor List and Quality Agreements
• Maintain the supplier performance metrics, trends data and communicates data to senior management and suppliers, as appropriate.
• Writes and reviews Quality Agreements between the Product Owner Site and the contracted facility.
• Assist in other functions in the department, as needed.

Basic Qualifications

• Minimum of a 2-year degree or certification in a technical program; a Bachelor's degree in a scientific or technical field, preferred.
• 2 years of experience in a cGMP environment, preferred.
• Prior quality assurance experience in an FDA regulated industry and working knowledge of quality systems (cGMP) and regulatory requirements (21CFR, Parts 11, 210 and 211) preferred.
• Basic competence with medical and therapeutic terminology.
• Knowledge of statistics, preferred.

Other Requirements

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

Fluency in English and excellent comprehension