QA Specialist

Description

Supports the Quality Function that they are responsible for within Operations. This could include: Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation, Quality Engineering, Training and Regulatory Compliance.
Quality Associate will maintain high quality levels on all aspects of their job while achieving high levels of efficiency.
Responsible for various aspects of quality assurance and quality control related to their functional area.
Ensures that product within the plant is consistently manufactured in conformance with company Quality System requirements and all applicable regulatory requirements.
Support troubleshooting and resolution of quality compliance issues.
Communicates with Management for Quality Management Review, Quality Initiatives, etc.
Quality decisions related to their functional area to ensure compliance with company Quality Systems and cGMPs.
Review of GMP commercial batch records
Working on the production floor

Qualifications

Bachelor's Degree required
1-2+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical or biologics industry
Must be familiar with use of electronic document management and laboratory information management.
Must be familiar with Quality Systems as well as cGMP and other regulatory requirements.
Strong communication skills, both oral and written
Whether it is through manufacturing or quality control, a certain level of quality experience is necessary.
Some form of review experience: data or record review
1+ years within a manufacturing facility
Prefer some work with investigations
Experience with document revisions is a bonus
Knows EDMS system
Shift: Monday to Friday 9-5 or 10-6 is ideal

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.

Synectics is an equal opportunity employer.
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