Field QA Specialist jobs in United States
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Synectics Inc. · 5 days ago

Field QA Specialist

Synectics Inc. is seeking a Field QA Specialist responsible for quality activities in accordance with policies, standards, procedures, and Global cGMP. The role includes performing QA on the floor activities, ensuring manufacturing compliance, and developing and revising procedures.

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Responsibilities

Perform QA on the floor activities
Ensure manufacturing compliance with applicable procedures and batch records
Perform real time review of manufacturing batch records
Review manufacturing shop floor documentation
Develops and revises procedures

Qualification

Quality Assurance experienceCGMP knowledgeFDA regulationsGMP Manufacturing knowledgeQuality processes knowledgeAnalytical thinkingPlanningOrganizingProblem solvingConflict managementBuilding relationships

Required

Relevant college or university Associate's or Bachelor's degree required
Minimum 4 years relevant work experience, with experience in a Quality Assurance role
Equivalent combination of education and experience might be acceptable
Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking
Understands continuous improvement and improves efficiency and productivity within the group or project
Builds relationships internally within and with cross functional teams
Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments
Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies
Routinely recognizes and resolves Quality issues; Informs management of proposed solutions
Seeks management guidance on complex issues
Able to recognize conflict and notify management with proposed recommendations for resolution
Must possess an independent mindset. Work is self-directed
Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision
Confident in making decisions for non-routine issues
Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution
Able to prepare written communications and communicate problems to management with clarity and accuracy
Able to effectively multi-task
Knowledge of US and global cGMP requirements
Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality Risk Management principles
Must be skilled in planning and organizing, decision-making, and building relationships
Knowledge of quality processes, change control, product complaints, deviations, investigations, and CAPA management
Required manufacturing shop floor documentation experience
Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles

Preferred

Prefer to also have knowledge of GMP Manufacturing operations and processes

Benefits

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Company

Synectics Inc.

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Synectics Inc. is a premier national staffing firm founded in 1984, headquartered in Chicago, Illinois.

Funding

Current Stage
Growth Stage

Leadership Team

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Melissa Lounds
Executive Vice President, Strategic Partnerships
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Company data provided by crunchbase