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ManpowerGroup Biopharma QA Specialist in Cambridge, Massachusetts

Our client, a pharma company is seeking a Biopharma QA specialist to join their team. In this role you will evaluate incoming materials to ensure they meet the required standards and specifications. You will collaborate closely with procurement, manufacturing, quality control, and quality assurance teams to maintain high standards of quality throughout the supply chain process.

Job Title: Biopharma QA Specialist

Location: Cambridge MA 100% onsite

Pay Range: $60 to $74 p/h w-2 depending upon experience

What’s the Job?

  • Material Inspection: Conduct thorough review of documentation of incoming materials to ensure they meet quality standards and specifications. Release materials in SAP and provide final quality decision.

  • Documentation and Record-keeping: Maintain accurate records. Ensure all documentation meets ALCOA principle, is organized, and accessible for reference and auditing purposes.

  • Supplier Communication: Communicate effectively with QA suppliers team regarding quality issues, non-conformances, and corrective actions related to incoming materials. Collaborate withprocurement and QA suppliers team to address any quality concerns and ensure timely resolution.

  • Root Cause Analysis (RCA): participate on RCA, investigate root causes of quality issues or non-conforming materials, and implement corrective and preventive actions to prevent recurrence.Compliance Authority for deviations, CAPA and change controls.

  • Quality Assurance Support: Provide support to the quality assurance team in developing and implementing quality assurance procedures, protocols, and standards for incoming materials.

  • Continuous Improvement: Identify opportunities for process improvement and efficiency enhancements in the incoming material lifecycle. Propose and implement solutions to optimize quality assurance procedures.

  • Compliance: Ensure compliance with relevant regulations, standards, and industry best practices pertaining to incoming material quality assurance.

  • Oversight of the incoming material process and warehouse activities

  • Create, revise and approved standard operating procedures in accordance with guidelines

  • Support incoming material qualification for phase III requirements including material specifications and release requirements

  • Additional responsibilities as needed by site priorities and Quality, Business or Safety requirement

What’s Needed?

  • 8+ years of industry experience (6+ years of QA experience) for a biopharma company

  • Excellent attention to detail and accuracy in data collection and analysis.

  • Ability to interact confidently with internal stakeholders.

  • Analytical mindset with the ability to problem-solve and perform root cause analysis.

  • Bachelors degree in a relevant field such as Quality Assurance, Chemistry, Biology, Engineering, or related discipline.

  • Proven experience in quality assurance or quality control, preferably in a manufacturing or production environment.

  • Strong knowledge of quality assurance principles, practices, and methodologies.

  • SAP Experience: Proficiency in using SAP or similar enterprise resource planning (ERP) systems to review material-related documentation, track inventory, and facilitate communication with internal stakeholders.

  • Experience in generating reports, conducting transactions, and navigating within SAP modules related to materials management, CAPA, Unplanned Events and Change Control is highly desirable.

What’s in it for me?

  • Medical, Dental, Vision, 401k

  • Weekly pay with direct deposit

  • Consultant Care support

  • Free Training to upgrade your skills

  • Dedicated Career Partner to help you achieve your career goals

If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.

ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.

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