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Curia Supervisor, Quality Assurance in Burlington, Massachusetts

Supervisor, Quality Assurance in Burlington, MA

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

The Supervisor, Quality Assurance is an integral part of the Curia team, contributing to our success by being knowledgeable of industry regulations, industry best practices, and phase appropriate quality systems. He/she must be quality focused and understand aseptic processing and the associated quality systems. He/She is responsible for oversight of quality operations activities. In this capacity, the incumbent can perform the final disposition of executed batch records, approve quality departures (i.e. unplanned deviations, CAPA's, planned deviations), and approve procedures. Additional responsibilities may include representing Quality Assurance in operations meetings, project meetings, client meetings, and inspections. The Quality Assurance Supervisor must be highly organized demonstrating excellent communication skills and may organize/delegate workload among Quality Assurance.

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.

In this role, you will:

  • Responsible for working cross-functionally with Manufacturing, Process Engineering, Facility, Inspection and Project Management on Quality Assurance (QA) activities such as the following:

  • Executed/Unexecuted Batch Record Review.

  • Executed/Unexecuted Validation/Facility Protocols/Reports.

  • Investigation review/writing including Unplanned Deviations, Temporary Change Controls, Environmental Monitoring Excursions and Equipment Excursions.

  • SOP writing, review and revision.

  • Reviewing Change Controls and CAPA

  • Reviewing Facility Work Orders prior to filing.

  • The QA Supervisor works in coordination with the QA Management to ensure client timelines are on schedule and attainable

  • Work in coordination with QA Management to ensure QA staffs are appropriately trained and procedures are being followed

  • Oversee and Manage visual inspection activities associated with clinical and commercial drug product

  • Assist in assuming 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

  • Participate in regulatory and client audits

  • Responsible for training and mentoring team members

    Qualifications and background to be successful in this role:

    Required

  • Bachelor’s degree in life science field; alternate fields of study may be considered in combination with significant Aseptic/Microbiological industry experience

  • 5-8 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

  • U.S. employees of Curia Global Inc. and its subsidiaries (a “Company”) 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.

    Preferred

  • Former supervisory experience preferred

  • Previously experience in the review of validation (process, IOPQ) protocols and reports preferred

  • Knowledgeable in FDA, cGMPs (21 CFR, 210/211, 820, and 600); Eudralex volume 4- annex 1 ISO 9001 and 13485 a plus

    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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