Quality Assurance Manager

2 weeks ago


Merrillville, Indiana, United States Albanese Confectionery Full time
Job Title: Quality Assurance Manager

The Quality Assurance Manager plays a pivotal role in ensuring the highest standards of quality and compliance within our organization. This individual is responsible for developing and implementing quality management systems that align with regulatory requirements and company policies.

Key Responsibilities:

  • Develop and maintain quality objectives that align with company goals and policies.
  • Train and evaluate Quality Assurance team members to ensure compliance with cGMP, SQF, BRC, HACCP, and food safety standards.
  • Maintain all relevant Food Safety and Quality certifications.
  • Assist with third-party and customer audits, ensuring seamless communication with regulatory agencies.
  • Collaborate with cross-functional teams to maintain compliance with product specifications, labeling, and regulatory standards.
  • Support corrective action and continuous improvement programs to drive process excellence.
  • Manage quality programs to ensure continuous production consistent with established standards.
  • Review and update SOPs, policies, and processes to ensure cGMP standards are met.
  • Support master manufacturing record creation, batch record review, and product release.
  • Participate in material review and evaluate recommendations for product disposition.
  • Support change control process to ensure key cGMP documents are appropriately controlled.
  • Communicate effectively with internal and external customers.

Requirements:

  • Minimum of 5 years of experience in a management role, with career progression to quality management.
  • Experience in dietary supplement manufacturing is a plus.
  • Understanding of 21 CFR Part 117 and 21 CFR Part 111 regulations.
  • Experience in participating in 2nd and 3rd party audits required.
  • Excellent interpersonal skills, with the ability to work effectively in a team environment.
  • Hard worker who is a self-starter and proactive.
  • Good verbal and written communication skills.
  • HACCP, SQF, and/or PCQI certification a plus.

Education:

  • Minimum of a Bachelor of Science degree or commensurate experience.

Working Relationship:

  • Reports to the Quality Operations Manager.
  • Communicates regularly and has a strong relationship with team members in multiple departments.
  • Communicates and meets periodically with other departmental leaders.


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