What are the responsibilities and job description for the QA Specialist position at Synectics Inc?
Job Description
Job Description
Description :
Support for Quality and Compliance activities assigned during product development and transfer
Provide timely quality support of tasks assigned
Develops and applies knowledge in all aspects of product formula and ingredient labeling
Develops knowledge of regulations impacting areas of work (i.e., USP, EP / BP, JP, ICH, WHO, TGA, ISO, PICS)
Develops understanding of quality requirements at local, corporate and regulatory levels to assist colleagues and Stakeholders in formulation management activities
Support review of formula related documents to ensure accuracy and traceability of information provided
Support formula activities; review and approval
Assist colleagues and Stakeholders to ensure work is conducted following sound scientific practices and supporting data : Change Controls, Raw Materials, Site formula manufacturing records, COAs, Composition statements
Develop technical writing skills utilizing IT systems (MS Word, Excel and PowerPoint) and be familiar with audit tracking systems (e.g., CAPAs) and regulatory submission management submissions
Works with management supervision
Works with management to identify and resolve potential issues
Qualifications :
Bachelor of Science Degree
Chemistry, Pharmacy, Biology or Related Science
Understand quality strategies throughout organization that promote efficient, agile and compliant processes for formula management
Ability to understand manufacturing, packaging, clinical labeling, and analytical testing requirements to identify complexities in each area and the interdependencies between them
Understands applicable GMP, BOH, and Regulatory Affairs regulations and guidelines
Analytical skills and laboratory experience
Capacity to work in global and multidisciplinary environments
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.
