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Senior Quality Assurance Specialist - External Quality

Apex Systems
Cambridge, MA 02138
Full-time
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Job Description

Senior Quality Assurance Specialist, External Quality 1105677 Job Scope Purpose Our Cambridge based client is in need of an experienced QA specialist to join their team. Our client will consider an experienced Sr. QA individual with knowledge of vendor CMO clinical drug production, and it's not essential to have worked directly with the CMO as a liaison. Strong communication and good knowledge of QA is an essential component however. Please apply if you are ready to join an exciting group! Primary Job Responsibilities Provide QA leadership for Ocular programs and the QA Ocular team Act as QA Lead for tech transfer, process development, and process validation for programs Quality Assurance Lead for external collaborations to provide quality system expertise and help identify solutions and ensure compliance to GMP Author, review and approve GMP documentation (SOPs, batch records, protocols, technical reports, test methods, protocols, specifications, and summary reports to support GMP manufacturing). Support External Quality partnerships as required in the initiation and follow up of deviations, CAPAs, and change controls. Build on relationships within our CTOs and CMOs ensuring issues impacting quality control testing are tracked and resolved in a timely manner. Support projects, and global processes alignment (internal and external) as well as continuous improvement and initiatives. Review executed batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, and that all limits and specifications have been met. Review and approve deviations, change controls and CAPAs for appropriateness, completeness and to meet internal procedures and regulatory expectations. Work collaboratively with cross functional teams, partners, and vendors to gather background knowledge needed to complete assignments. Develop and maintain Quality Agreements with contract manufacturers, suppliers, and laboratories Plan and execute work independently and consult with supervisor as needed. Supports the organization in maintaining inspection readiness. Review and approve validation protocols and reports to ensure compliance Review stability protocols and reports Conduct internal and external audits as required, track progress, and trend results Primary Job Requirements A Bachelor's or Master's degree in biology, chemistry or other life science and at least 7 years of relevant industry experience in Quality Assurance in a PharmaceuticalBiotech GMP environment A solid understanding of applicable regulations and guidelines pertaining to pharmaceutical product development. manufacturing, testing and clinical operations Experience with GMP's in a working manufacturing environment strongly preferred A working knowledge of GMP requirements for Clinical Trial Material in both the US and EU including sterile manufacturing strongly preferred Certified Quality Auditor (CQA) would be a plus Investigational skills including Root Cause Analysis and Product Impact Assessments Ability to manage multiple projects with minimal oversight in and evolving environment Strong communicator and collaborator who possesses a flexible approach to problem solving and ability to apply risk-based decision making Occasional travel will be required About Stratacuity Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENTTrademark Stratacuity is an Equal Employment OpportunityAffirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us. Code RegQA EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or
Posting ID: 600968366Posted: 2021-03-02