What are the responsibilities and job description for the Quality Assurance Specialist position at Synectics Inc.?
Description
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.
- The Specialist, Quality ensures compliance with quality system's procedures and assessing regulatory and quality risks in activities and processes according to regulatory agency guidelines and company practices.
- Accountable for routine Quality Assurance responsibilities related to the production and disposition of products manufactured and tested
- Provide quality assurance support across technical operations functions (i.e. Manufacturing, Facilities & Engineering, Supply Chain, Quality Control, Analytical Development, Product Development/Manufacturing Sciences & Technology) to assure compliance to the quality manual and maintain collaborative quality relationships.
- Lead deviations and laboratory investigations related to GMP manufacturing and analytical testing, respectively, with cross-functional owners.
- Determine corrective/preventative actions (CAPA) and Verification of Effectiveness (VoE) and drive on-time implementation and closure.
- Work with appropriate partners to manage change controls in a phase appropriate manner for clinical stage products that supports quality risk management (i.e. New
- Product Introduction, New Facility, & Manufacturing Process Change Controls).
- Provide ILT trainings for annual GMP/GDP, Quality Manual, Quality Risk Management, Deviation/CAPA, Change Control.
- Work with QA doc control to ensure accurate issuance of batch record documentation (i.e. lot/media batch records and in-process/QC/final product labels) to manufacturing.
- Review routine manufacturing batch documentation and quality control data for in- process and finished product to support disposition and lot closure.
- Perform approval of equipment alarm acknowledgements, equipment activation and PM/Calibration schedules in computerized asset and alarm management system(s).
- Review routine material release documentation for quality release of raw materials used for manufacturing and quality control testing.
- Working Days/Hours: 9am-5pm Sunday- Thursday OR Monday-Friday (possible weekend work)
- MA/MS in Biology, Chemistry, Microbiology, Engineering, or a related field is required; OR
- BA/BS with 2 years; OR
- Associate's degree with 4 years; OR
- High School diploma with 5 years of Quality Assurance or GMP experience.
- Knowledge of and ability to apply GMP in conformance to US standards.
- Proficient in cGMP regulations, quality systems and regulatory requirements.
- Experience writing, evaluating and closing investigations, CAPAs and change control records.
- Adapt best practices for stage appropriate products.
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.
Salary : $32 - $41