Scientific Protein Laboratories, LLC · 1 day ago
Manager Quality Assurance
Scientific Protein Laboratories - Waunakee, WI 53597
Full-time
Onsite
Senior Level
5+ years expScientific Protein Laboratories (SPL) is a world leader in biosourced pharmaceuticals located in Waunakee, Wisconsin. They are seeking a Manager of Quality Assurance responsible for organizing quality supervision, managing quality-related investigations, and overseeing batch record review and product release activities to ensure compliance with GMP and company quality standards.
BiotechnologyManufacturingPharmaceutical
Responsibilities
Plan, organize, and oversee on-site quality supervision activities to ensure GMP compliance and effective execution of procedures
Review and approve quality supervision documentation, ensuring timely identification, escalation, and resolution of quality issues
Review and assess original GMP records, including deviation investigations, change controls, and equipment malfunction documentation
Oversee and authorize in-process control (IPC) release activities in accordance with approved procedures
Establish, organize, and maintain compliant processes for quality investigations and CAPA execution
Provide technical oversight, guidance, and review of deviation and customer complaint investigations conducted by investigators
Ensure investigations and CAPAs are completed on time, thoroughly documented, and effectively closed
Monitor and track CAPA implementation and effectiveness to drive continuous improvement of the quality system
Establish and maintain procedures governing batch record review and product disposition
Ensure timely and thorough review of batch production and testing records, with prompt resolution of discrepancies
Organize and oversee product release activities, ensuring compliance with regulatory requirements while maintaining operational efficiency
Act as a primary Quality interface with Operations, Quality Control, and Engineering functions
Facilitate cross-functional resolution of quality issues and provide GMP guidance to support operations
Report quality metrics, deviation and CAPA trends, and improvement initiatives to management
Provide quality and compliance input for cross-functional projects and process improvement initiatives
Lead and manage on-site QA and Operations On-Site QA teams, defining roles, responsibilities, and performance expectations
Coach and develop team members to strengthen competencies in investigations, CAPA management, and GMP documentation
Assess workload and resource needs, adjusting staffing and priorities to ensure business and compliance requirements are met
Support internal and external audits and regulatory inspections
Ensure timely development, implementation, and closure of corrective actions arising from audit and inspection findings
Qualification
Required
Bachelor's degree or above in Pharmacy, Pharmaceutical Engineering, Biology, Chemistry, or related fields
5 plus years, minimum of 2 years in management
Preferred
Master's degree or above in Pharmacy, Pharmaceutical Engineering, Biology, Chemistry, or related fields
10+ years, minimum of 2 years in management
Benefits
Competitive compensation
Excellent benefits package - including Medical, Dental and Vision on Day 1
Life and AD&D Insurance
Short and Long-term Disability
Health and Flexible Saving Account options
Employee Assistance Program
Generous vacation
Paid Holidays
401k
Advancement opportunities
Team-oriented environment
Community involvement
Company events and more
Company
Scientific Protein Laboratories, LLC
Scientific Protein Laboratories (SPL) has been a leading global supplier of high quality active pharmaceutical ingredients (APIs) for over three decades.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
David Knauss
Chief Financial Officer
Recent News
2024-12-28
Company data provided by crunchbase