Quality Assurance Specialist II
Our client has an opportunity for a Quality Assurance Specialist II. In this roll you will review operations documentation for compliance, follow regulations, and is in line with company procedures and meets the customer needs.
- Collaborate with Operations and Quality groups to resolve discrepancies
- Communicate with customers to ensure their needs are met
- Prepare Certificate of Analysis and Certificate of Conformance
- Responsible for oversight, implementation and success of company’s NCM/CAPA system based on FDA regulations and ISO requirements
- Review root cause analysis, comprehensiveness, accuracy and compliance to cGMPs and SOPs
- Joint leadership and support to the Material Review Board, responsible for working with the team to resolve MRRs, Customer Complaints, and coordinate Corrective Action
- Cross-functional support to Quality, Engineering, Operations and Sales
- Initiate, writes the investigation, and follow up re MRRs, Deviations and Incidents
- Training and Support for co-workers on CAPA systems
- Back-up other Quality Assurance Specialist and Documentation Specialist as needed
- Authors/Revises SOPs related to Quality Assurance area.
Our client services include formulation, optimization, blending, coating, converting, primary packaging, secondary cartoning, and kitting to commercially manufacture transdermal and oral thin film drugs.
Benefits available to team members:
- Medical / Dental Insurance
- Paid Holiday/ Vacation / PTO
- 401K w/ company match
- Life and Short/Long Term Disability
- Flex Spending Account
- 2-year Technical Degree- Required! Or 4 year Technical Degree – Preferred!
- 2-5 years Quality Assurance/Quality Control experience in a manufacturing environment; medical device, pharmaceutical industry experience – Preferred!
- 2-5 years’ experience working in cGMP regulated environment
- Collaborative Team Player
- Excellent interpersonal and communication skills
- Excellent organizational skills
- Ability to effectively prioritize and manage multiple priorities
- Knowledge of FDA standards