Quality Assurance (QA) Compliance Specialist II

Job-ID29031369Reference26-22116Purpose: Describe the primary goals, objectives or functions or outputs of this position. 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.?br/> Assess operations/distribution outages and deviations to determine compliance with specifications and procedures. Responsibilities: List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• 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

Qualifications: List required and preferred qualifications (up to 10). Include education, skills and experience.

• Bachelor’s degree is preferred
• 4 years in Quality Assurance, Process Support, Engineering, Manufacturing/Operations, Distribution or similar area.
• Reviewing problem solving situation
• Understand manufacturing / distribution process
• Product responsibility for compliance troubleshooting
• Audit interface
• Creativity in resolving issues
• Negotiation skills with Mfg. / Distribution customers
• 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.

EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”