Sr.QA Specialist - Incoming Materials

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Job description

Sr. QA Specialist Incoming Materials needed for a contract opportunity with Yoh Scientific's client located in Cambridge, MA.

This position is for a major pharmaceutical company and requires a bachelor's degree and at least 8+ years of industry experience (6+ years of QA experience) for a biopharma company.

Schedule Monday to Friday, 1st shift (hours may vary).

Key Responsibilities:

• 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 with
• procurement 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 company guidelines
• Support incoming material qualification for phase III requirements including material specifications and release requirements

Qualifications

• Bachelor's degree in a relevant field such as Quality Assurance, Chemistry, Biology, Engineering, or related discipline.
• 8+ years of industry experience (6+ years of QA experience) for a biopharma company
• Knowledge of Good Manufacturing Practices (GMP) and regulatory requirements in pharmaceutical industry.
• Experience working with SAP's Quality Management (QM) modules or similar quality management software within an ERP system.
• Familiarity with SAP's Materials Management for procurement and inventory management.
• Analytical mindset with the ability to problem-solve and perform root cause analysis.
• 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.

Opportunity is Calling, Apply Now!
Contract: 8-month contract with possibility of extension and/or conversion.
Pay rate: $65 - $77.82 per hour depending on experience, W2.
Recruiter: Ery Baniqued
What's In It For You?

We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.

• Medical, Dental & Vision Benefits
• 401K Retirement Saving Plan
• Life & Disability Insurance
• Direct Deposit & weekly ePayroll
• Employee Discount Programs
• Referral Bonus Programs

Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here!

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, 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, disability, or status as a protected veteran.

Visit to contact us if you are an individual with a disability and require accommodation in the application process.

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