Quality Assurance Specialist

Quality Assurance Specialist in Burlington, MA

AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. The Quality Assurance Specialist III is responsible for maintaining Quality databases and providing on-the-floor QA presence and oversight to the manufacturing operation. The QA Specialist’s role will include identifying compliance risks in the operation prior to and during execution, avoiding deviation whenever possible as well as managing immediate corrective action such that a) adherence to cGMP’s and internal procedures/policies is maintained, b) appropriate immediate corrective action is implemented and effectively documented in order to provide traceability and substantiation of any claims to be made in the investigation. This position primarily works in the cGMP production areas to manage adherence to the quality system and to initiate and assist in the initiation and resolution of deviations. 

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

Responsibilities:

• Responsible for working cross-functionally with Manufacturing, Process Engineering, Facility, Inspection and Project Management on  Quality Assurance (QA) activities such as the following: On-the-floor support and oversight of manufacturing operations, Executed/Unexecuted Batch Record Review, Executed/Unexecuted Validation/Facility Protocols/Reports, Reviewing Change Controls, Reviewing Facility Work Orders prior to filing.
• The QA Specialist III works in coordination with the QA Management to ensure client timelines are on schedule and attainable.
• Assist in responsibility for the AMRI compilation of documentation, systems and controls to ensure inspection-ready quality systems (ISO, FDA, QP, EMEA) for domestic and international inspections and registrations.
• In conjunction with QA management, coordinate day to day activities on an as needed basis and provide support to QA specialists.
• Educate and train manufacturing/process engineering personnel to execute production in full accordance with cGMP’s and AMRI’s quality system to ensure real-time compliance.
• Represent AMRI Quality Assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and appropriately documented.
• Reviews Un-executed /Executed batch records and quality control testing for compliance with internal SOPs and specifications.
• Monitor Operations personnel for adherence to SOP’s. Report back to Manager of QA as well as area functional management as to personnel performance, highlighting those areas and individuals in need of improvement.
• Reviews and approves Document Change Notifications for SOPs, test methods, raw material specifications, protocols (stability, validation, etc.) and batch records.
• Reviews and approves SOPs, test methods, raw material specifications, protocols and executed validation documentation.
• Authors or revises SOPs.
• Performs manufacturing area and labeling clearances as well as inspection of material.
• Reviews and approves CAPAs, Deviations, Change Controls, Equipment Excursion Reports
• Assists in performing investigations.
• Performs internal audits and weekly walkthroughs.
• External audits for Supplier qualification.
• May respond or manage responses to clients regarding manufacturing and/or documentation issues.
• Assists in developing and delivering training.
• Assists tracking and follow-up on Deviations, Change Controls, Investigations, and CAPAs.
• Develops and/or maintains Quality System metrics for Management Review.
• Provides on the floor support to manufacturing operations.
• Perform QA visual inspection activities associated with clinical and commercial drug product.
• Participate in regulatory and client audits.

Qualifications

• Bachelor’s Degree in the Life Science field; alternate fields of study may be considered in combination with significant Aseptic experience
• 6+ years’ experience of pharmaceutical/biotechnology or medical device industry experience; Minimum of 5 years’ experience in Quality Assurance
• Excellent written and verbal presentation and communication skills
• Strong problem solving skills, with the ability to resolve conflict
• Ability to effectively present information to management and/or peers
• Comfortable working independently in combination with individuals in other departments across the organization

All interested applicants must apply online.

AMRI is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.