Manager, QA Operations

Alphazyme; Town of Florida (NY); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Comprehensive medical plans

Retirement contributions

Paid Time Off

Fertility assistance

Job summary

Alphazyme is seeking a Manager for QA Operations to ensure compliance with quality standards. The role involves managing QA operations, implementing policies, and ensuring adherence to ISO 13485:2016 standards.

The ideal candidate has a Bachelor's Degree in a relevant discipline, 3-5 years of managerial experience, and knowledge of quality assurance methodologies. This position is located in the Town of Florida, NY and offers a chance to make a significant impact in the life sciences sector.

Qualifications

• 3-5 years of managerial experience in biotechnology industry.
• 1-3 years of supervisory experience.
• Thorough understanding of ISO 13485 and federal regulations 21 CFR 820.

Responsibilities

• Manage QA department day to day operations.
• Evaluate documentation for continuous compliance.
• Support Quality Control with customer complaints and investigations.

Skills

ISO 13485 certification

Good Manufacturing Practice (GMP)

Quality assurance methodologies

Analytical testing standards

Communication skills

Problem solving

Leadership skills

Education

Bachelor’s Degree in Life Science, Biology, Chemistry or Pharmaceutical

Job description

Who we are

Maravai LifeSciences translates extraordinary science into everyday miracles, helping biotech, biopharma, and life sciences companies everywhere deliver novel vaccines, therapeutics, and diagnostics. We are global leaders in providing products and services within the fields of nucleic acid production and biologics safety testing to many of the world's leading biopharma, vaccine, diagnostics, and cell and gene therapy companies.

At Maravai, we believe that diverse perspectives are the foundation of innovation. Through an inclusive and equitable culture where every team member is inspired to bring their best selves to work, we cultivate an environment in which we can lead together, providing differentiated value to our customers, and enabling the miracles of science. For over 35 years, Maravai’s portfolio companies have served as a catalyst for innovative, lifesaving technology for humanity. Pioneering nucleotide research since its inception, we are now leading the way in the rapidly expanding mRNA market.

Your next role as a Miracle Maker

Maravai LifeSciences is seeking a #MiracleMaker to join our Quality Assurance team as a Manager, QA Operations. The Manager, QA Operations is responsible for the implementation of policies and procedures to ensure adherence to production quality standards and oversight of 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.

How you will make an impact

• 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

The skills and experience that you will bring

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

#LI-Onsite

The benefits of being a #MiracleMaker

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

Benefits may vary by region and employment type and do not apply to temporary employees or contractors. See a comprehensive list of benefits at our Benefits & growth site at https://www.maravai.com/careers/benefits-and-growth/

To view more opportunities to become a #MiracleMaker, visit our career site at https://www.maravai.com/careers/

Alphazyme, a Maravai LifeSciences company, is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation, gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

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