Job Description

Job Description

Job Description

Job Description

• The QA Specialist Demonstrates sufficient depth of knowledge within own work area in order to perform hands-on routine QA tasks.

• This role supports Operations including batch record, investigation, and document review, and disposition activities.

• Resolve routine quality issues related to product manufacture and testing with guidance/coaching.

• Project work, as needed, will also be expected.

• Other essential duties and responsibilities in quality assurance include: Provide Quality Assurance expertise to colleagues On and off the Manufacturing floor as required.

• Identify continuous improvement opportunities based on metrics and drive consistency through the process to align with standard processes and quality systems.

• Conduct regular Production areas walkthroughs (Area product clarences, GMP and compliance walkthroughs)

• Conduct On floor QA review of executed batch records and Logbooks to assure compliance with regulatory standards and regulatory filing.

• Assist Quality Operations Deviations and Product Floor Support for all planned and unplanned manufacturing deviations.

• Escalate issues as appropriate to the Quality Assurance Management in a timely manner.

• Maintain regulatory compliance in accordance with current Good Manufacturing Practices.

• Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives.

• Quality Assurance approval of SOPs, Campaigns start up Form and QA validation protocols and reports.

• Maintains inspection readiness and supports internal/external audits as needed.

• Interface with Regulatory Agencies in audits.

Qualifications :

• Ability to work in a fast-paced environment and be able and willing to juggle priorities as required.

• Ability to gown into cGMP Manufacturing areas and adhere to governing gowning procedures as appropriate.

• Ability to stand for 1 hour at a time, walk long distances and bend to obtain items from lower shelving/cabinets.

• Occasional minimal lifting up to 20lbs.

• Bachelor's degree with 1-2 years of experience in GMP Pharmaceutical manufacturing environment required.

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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