Quality Manager

Responsibilities:

• Maintains Non-Conformance System & Investigations, including contacting appropriate people to resolve and providing guidance and strategies to various groups within the organization.
• Frequently interacts and partners with Operations, Purchasing and other departments to develop and administer all aspects of current and expanding quality processes for a successful cross-functional team.
• Exercises judgement within defined practices and policies in critical thinking and problem solving.
• Manage a team of QA/QC staff to ensure all members are competently performing their duties and are trained in all quality requirements.
• Lead process improvement and problem-solving efforts with other departments
• Assists with internal audits.
• Liaison with 3rd Party Testing Laboratories
• Responsible for Quality Review of Batch Record for release of product.
• Maintains Document and Data/ Records Control.
• Maintains all Quality System Records.
• Reviews and approves other documents: QC sheets, Lab documents, Certificates of Analysis.
• Issues and maintains NCR, COR, and Deviation system.
• Reviews and approves other documents: QC sheets, Lab documents, Certificates of Analysis, Cleaning/Sanitizing.
• Seeks answers and information regarding customer or in-house problems with product quality or performance.
• Performs other related duties as assigned or requested.

Qualifications:

• Bachelor’s degree in science, engineering, or technical field.
• Minimum 3 years’ experience in FDA regulated environment.
• Minimum 3 years’ experience working in a Quality Department.
• Must have cGMP Experience.
• Ability to perform systems, process, and product audits.
• Ability to work efficiently in a fast-paced, high-volume environment.
• Strong attention to detail and strong sense of urgency.
• Well organized with excellent communication skills, leadership, and interpersonal skills
• Ability to maintain confidentiality.
• Strong analytical and effective problem-solving skills.
• ASQ Certifications.
• Ability to work well as part of the Quality team.
• Computer skills, including Microsoft Office.
• Ability to manage multiple projects and meet deadlines.

#MMSOH

Job Type: Full-time

Pay: $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work Location: In person