Overview
Quality Control Manager Jobs in Eau Claire, WI at Veritas Steel LLC
Position Summary:
As Supervisor of Quality Operations, you will ensure excellence in aseptic manufacturing, lead critical quality processes, and drive continuous improvement. At Empower, your leadership will directly support our mission to deliver innovative, affordable medications that improve lives and expand access to life-changing treatments.
Duties and Responsibilities:
Supervises daily operations of Quality Operations, focusing on real-time floor oversight, batch record review, lot disposition, and investigation management for a three-shift aseptic sterile filling and finishing operation.
Leads and improves batch release processes to ensure timely disposition within cycle times; streamlines compounding, validation, change control, laboratory processes, and risk assessment procedures.
Acts as a quality subject matter expert for procedures and specifications, ensures team cross-training for environmental monitoring, and guides the team in achieving quality-first outcomes through incident and Corrective and Preventive Action (CAPA) processes.
Leads direction of investigations into deviations, excursions, product non-conformances, and complaints; oversees root cause analysis and CAPA to address audit findings and drive continuous improvement.
Reviews and approves change controls, test data, and deviation reports to ensure adherence to standards and regulations; reports findings to influence behavioral and operational change.
While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.
Knowledge and Skills:
Demonstrates leadership, effective communication, and organizational skills, with the ability to work both autonomously and as part of a team to resolve problems.
Possesses knowledge of pharmaceutical manufacturing, United States Pharmacopeia <797>, current good manufacturing practices, Food and Drug Administration regulations (21 Code of Federal Regulations Parts 210, 211), and International Council for Harmonisation regulations, with proficiency in computer software, particularly SharePoint.
Key Competencies
Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
Resourcefulness: Secures and deploys resources effectively and efficiently.
Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
Ensures Accountability: Holds self and others accountable to meet commitments and objectives.
Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.
Values
People: Our people define who we are as a company, and we believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth.
Quality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produce.
Service: We are here to serve others. Every interaction with our patients, providers, employees and other stakeholders comes from a place of service.
Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care.
Experience and Qualifications:
Minimum of 5 years of experience in pharmaceutical quality, including 3 years in a supervisory role.
Bachelor of Science degree in a technical or scientific discipline with 5 years of experience in pharmaceutical quality.
American Society for Quality Certified Quality Auditor, Certified Manager of Quality/Organizational Excellence, or an equivalent certification preferred.
Benefits:
No-Cost Medication: Get your prescribed compounded medications at no cost, ensuring your health without the financial burden.
Onsite Health & Wellness – IV Therapy Drips: Rejuvenate with complimentary onsite IV Therapy drips, enhancing your well-being and energy levels.
Comprehensive Medical, Dental, and Vision Options: Choose from three medical plans tailored to your needs, plus options for dental and vision coverage for you and your family.
Telehealth visits: Access board-certified Doctors anytime, anywhere for you and your family.
Paid & Volunteer Time Off: Enjoy paid time off for personal pursuits and contribute to causes you care about with volunteer time off.
Paid Holidays (8 scheduled; 2 floating): Celebrate with eight scheduled holidays and two floating holidays, giving you flexibility and time for personal traditions.
Life & AD&D Coverage: Secure your and your family’s financial future with life and accidental death and dismemberment (AD&D) insurance.
FSA (Flexible Spending Account): Manage healthcare expenses smartly with pre-tax dollars in a Flexible Spending Account (FSA).
401K Dollar-for-Dollar Up to 4%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 4%.
Company Paid Long-Term Disability: Provided at no cost, which replaces 60% of your income if you become disabled for a long period of time.
Flexible Schedules: Balance work and life seamlessly with our flexible scheduling options.
Rewards & Recognition Program: Your hard work doesn’t go unnoticed – enjoy rewards and recognition beyond your paycheck.
Additional Voluntary Benefits
Accident Insurance: Pays a lump sum benefit to help cover expenses following an accidental injury.
Hospital Indemnity Insurance: Enhance your peace of mind with supplemental hospital insurance for unexpected stays.
Critical Illness: Protect your finances from the expenses of a serious health issue.
Short-Term Disability: Protect your income during illness or injury with short-term disability coverage.
Supplemental Life & AD&D: Add an extra layer of financial protection for you and your loved ones with supplemental life and AD&D coverage.
Legal Services: Access professional legal assistance to address concerns confidently.
Identity Theft Protection: Safeguard your identity and finances with our identity theft protection benefit.
Pet Insurance: Care for your furry family members with our pet insurance coverage.
Employee Assistance Program: Confidential counseling and support services for a holistic approach to your well-being.
Title: Quality Control Manager
Company: Veritas Steel LLC
Location: Eau Claire, WI