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AMRI Quality Assurance Specialist II in BURLINGTON, Massachusetts

Title: Quality Assurance Specialist II

Location: US-MA-Burlington

Job Number: 1003495

AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

The Quality Assurance Specialist II 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

  • Educate and train manufacturing/process engineeringpersonnel to execute production in full accordance with cGMP’s and AMRI’squality system to ensure real-time compliance

  • Represent AMRI Quality Assurance when managingissues that require immediate corrective action. Ensure such action takenis appropriate and appropriately documented

  • Reviews Un-executed /Executed batch records andquality control testing for compliance with internal SOPs andspecifications

  • Monitor Operations personnel for adherence to SOP’s.Report back to Manager of QA as well as area functional management as topersonnel performance, highlighting those areas and individuals in need ofimprovement

  • Reviews and approves Document Change Notificationsfor SOPs, test methods, raw material specifications, protocols (stability,validation, etc.) and batch records

  • Reviews and approves SOPs, test methods, raw materialspecifications, protocols and executed validation documentation

  • Authors or revises SOPs

  • Performs manufacturing area and labeling clearancesas well as inspection of material

  • Reviews and approves CAPAs, Deviations, ChangeControls, Equipment Excursion Reports

  • Assists in performing investigations

  • Performs internal audits and weekly walkthroughs

  • External audits for Supplier qualification

  • With supervision, may respond or manage responses toclients regarding manufacturing and/or documentation issues

  • Assists in developing and delivering training

  • Assists tracking and follow-up on Deviations, ChangeControls, Investigations, and CAPAs

  • Develops and/or maintains Quality System metrics forManagement Review

  • Provides on the floor support to manufacturing operations

  • Perform QA visual inspection activities associatedwith clinical and commercial drug product

  • Participate inregulatory and client audits

Qualifications:

· Bachelor’s Degree in Life Science field required

· 4 years of experience in Pharmaceutical/Biotechnology or Medical Device industry; Minimum of 2 years of experience in Quality Assurance

· Excellent written and verbal presentation and communication skills

· Strong facilitation 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.

Other Locations:

EOE Protected Veterans/Disability

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