Quality Assurance (QA) Compliance Specialist

Job Description

Job Description

Description:

• Assure compliance with FDA current Good manufacturing Practices (cGMP) and Good Distribution Practices (cGDP) regulations.

• Assure compliance with Corporate policies/procedures and provide guidance on operational processes, procedural issues and documentation content and adequacy.

• Assess operations/distribution outages and deviations to determine compliance with specifications and procedures.

• Site CAPA Coordinator/ administrator for shipment temperature management

• Audit Interface- FDA, supplier, customer inspection, corporate

• Project Management for Quality Initiatives

• Manage Validation Library

• Conduct product quality, diversion and distribution complaint investigations

• Manage warehouse temperature monitoring program

• Point Person for NPI launches

• Execute placement and removal of QA Holds in warehouse management system

• Manage/Post supplier audit data in appropriate database

• Manage market authorization process and Master Data Management

• Individual is also heavily involved in the analysis of complex technical data in all aspects of product acceptance.

• This position is heavily involved in product and process problem solving and works closely with R&D, Process Development, Manufacturing/Operations and Engineering.

Qualifications:

• Bachelor's degree is preferred

• 4 years in Quality Assurance, Process Support, Engineering, Manufacturing/Operations, Distribution or similar area.

• Reviewing problem solving situations

• Understand manufacturing / distribution process

• Product responsibility for compliance troubleshooting

• Audit interface

• Creativity in resolving issues

• Negotiation skills with Mfg. / Distribution customers

• SAP and CAPA experience

• Inspection experience

• GDP experience required

• Experience initiating non-conformances

• Long-term industry experience preferred

• OneVault preferred

• Change management experience, especially for SOPs

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 of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities

Company Description

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities