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Curia Quality Assurance Specialist III 1st Shift Sign on bonus offered and competitive starting salary in Burlington, Massachusetts

Quality Assurance Specialist III - 1st Shift in Burlington, MA

Curia 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

  • Other duties may be assigned

  • 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 CURIA 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 CURIA’s quality system to ensure real-time compliance.

  • Represent CURIA 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 Supervisor 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

  • Reviews and approves CAPAs, Deviations, Change Controls, Equipment Excursion Reports

  • Assists in performing investigations

  • With supervision, 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

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

Education:

  • Minimum 5-8 years’ GMP and QA experience in an FDA-regulated pharmaceutical environment

  • In lieu of a Bachelor’s degree, minimum 10-12 years’ experience in Quality Assurance within the pharmaceutical, aseptic, and/or microbiological industries may be considered

U.S. employees of Curia Global Inc. and its subsidiaries (a “Company”) hired after December 7, 2021 must be fully vaccinated against the COVID-19 virus and provide the Company with proof of vaccination as a condition of their employment except for U.S. employees who request and qualify under applicable law for disability and religious accommodations from the COVID-19 vaccine mandate. An applicant who receives an offer of employment from the Company for a position as a U.S. employee will be required to provide proof of vaccination, or to request and receive a disability or religious accommodation that the applicant is entitled to under applicable law, before their first day of employment or any earlier or later deadline specified by the Company in the offer letter. The Company is an equal opportunity employer and provides employment opportunities and makes employment decisions without regards to an individual’s disability or religion or on any other basis prohibited by applicable law.

Knowledge, Skills & Abilities:

  • 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. Curia 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.

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