QA Specialist

QA SPECIALIST II

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

Environment:

This client is one the world s leading suppliers to the pharmaceutical, biotech and specialty ingredients markets. We create products that support a healthier lifestyle and enhance ones quality of life.

• Title: QA Specialist II
• Location: Hayward, CA
• Industry: Pharmaceutical
• Hours: 8-5 Monday-Friday
• Salary: $55.70/HR determined by experience level
• Employment Type: Long-term contract

Position Summary:

This role is responsible for the review and approval of GMP documentation to ensure compliance in operational areas. Through their fundamental knowledge, assists manufacturing associates by providing Quality Assurance support for operational areas involved in the execution of GMP-related activities. Participates in deviations and root cause investigations. Focused responsibilities include batch record review, and review of QA Operations related SOPs to meet local, Global and Regulatory requirements.

Key Responsibilities:

• Responsible for the review and approval of cGMP documentation against Standard Operating Procedures in order to ensure compliance in Manufacturing processes.
• Raise deviations as needed in order to capture potential impacts to product
• quality.
• Revise or review standard operating procedures and submit procedural
• changes as needed to meet local, Global and Regulatory requirements.
• Co-represent QA in meetings or on project teams, learning decision making as a QA representative conferring with senior staff.
• Participates in deviations and root cause investigations.
• Identify areas of non-conformance. Complete minor deviations and support root cause investigations.
• Perform other duties as assigned.

Key Requirements:

• Effective interpersonal communication.
• Must have effective verbal and written communication skills.
• Effective organizational skills and ability to plan and suggest resolutions to technical problems.
• Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
• Trackwise, SAP, Excel.

EOE/ADA

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