Manager, QA Operations

Alphazyme • Jupiter, FL

6d • Onsite

About The Position

Maravai LifeSciences is seeking a Manager, QA Operations to join their Quality Assurance team. This role is responsible for implementing policies and procedures to ensure adherence to production quality standards and overseeing the Company’s electronic ISO 13485:2016 Quality Management System. The Quality Assurance Manager is expected to ensure compliance with operational, statutory, and regulatory requirements in support of the Company’s business objectives.

Requirements

• Bachelor’s Degree in Life Science, Biology, Chemistry or Pharmaceutical or related discipline
• 3-5 years of managerial experience in non-academic biotechnology related industry
• 1-3 years of supervisory experience
• Proven experience with: ISO 13485 certification, federal regulations 21 CFR 820 and 21 CFR Part 11
• Thorough knowledge of analytical testing industry standards and quality assurance methodologies
• Excellent communication and presentation skills are required
• Demonstrated scientific “problem solving” skills, translated into consultative selling process where the “win” is for both the client and the company
• Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance success of project and maintain strong relationships within all parts of company
• Proven ability to thrive in a start-up/change oriented environment
• Great attention to detail and results driven approach
• Self-starter with ability to organize and prioritize a diverse set of responsibilities to ensure that focus on growth and success of company is achieved
• Proven coaching, mentoring, team building and leadership skills

Nice To Haves

• Industry experience in a Good Manufacturing Practice (GMP) environment is preferred

Responsibilities

• Manage Quality Assurance department day to day operations, including implementing training and performance management activities for direct reports
• Implement and periodically evaluate documentation and policies to ensure continuous compliance to the quality, integrity, and efficiency standards set by the organization, the ISO 13485:2016 standard, and other statutory and regulatory requirements.
• Collaborate with management to identify and fill documentation and process gaps required to maintain QMS compliance and address CAPAs, NCs, and audit findings
• Author and maintain quality documentation, oversee timely reviews of all work instructions associated with production and quality control activities
• Support Quality Control with customer complaints and Out of Specification (OOS) investigations
• Actively participate on core teams and provide deliverables from QA on quality processes and required documentation practices from production through testing and shipment
• Implement and track metrics to monitor performance associated with Quality management
• Identify and implement efficiency improvement initiatives in support of Continuous Improvement
• Facilitate proactive solutions by collecting and analyzing quality data
• Manage Internal Audit Program
• Perform other functions and duties as required

Benefits

• Potential to change, improve, and save lives around the world.
• Opportunity to be a part owner in Maravai through RSU grants and optional employee stock purchase plans.
• Comprehensive medical plans and HSA/FSA options.
• Fertility & family planning assistance.
• A variety of additional optional benefits and insurance options, including pet insurance.
• Retirement contributions.
• Holidays & Paid Time Off.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager