Quality Manager

We are seeking a results-oriented and hands-on Quality Assurance Manager to help scale this high-growth business, without compromising the quality of products and core values, culture, and purpose. You'd be joining an organization with strong brands, trusted by over 30K hospitals and practitioners, along with a tenured, well skilled team.

Ideal candidate should have extensive quality experience in FDA GMP regulated industry, familiar with Quality Management System, managed SOP, Document Control, CAPA, Deviation, Change Control, training and complaint program. Strong analytical and scientific research ability to gain product knowledge quickly, and understand specification and testing. A critical thinker who will actively contribute to process improvement ideas and proactively help improve quality systems. Productive in fast-paced and high-pressure working environment.

DUTIES AND RESPONSIBILITIES:

• Mange SOPs including evaluating, writing/revising, maintaining, tracking and training.
• Manage consumer complaints and adverse event including investigation, response, trend analysis and record keeping. Assist customer service for product inquiries.
• Develop training program including establishing training curriculum, maintaining personnel training record. Conduct GMP, SOP training as needed.
• Manage document control system, and record keeping.
• Assist Supplier Qualification program for raw material ingredients, packaging components suppliers, CMOs, and 3rd party contract laboratories.
• Review supplier documents such as certificate, audit report, SOP, batch record, specification, deviation, CAPA. Evaluate cGMP compliance.
• Review COAs, specifications, internal change control, material review, deviation, CAPA. Follow up actions and evaluate effectiveness.
• Conduct internal audit. Support external 3rd party, FDA or any regulatory audit.
• Provide documentation and report for customer audit or request. Assist preparation and filling of regulatory and quality documentation.

• Responsible for following standard operating procedures and related systems that ensures company compliance and applicable regulations.
• Maintain compliance with federal, state and local regulations. Assist in Quality Management system improvement.
• Performs all applicable functions necessary as required by management

EDUCATION, TRAINING AND WORK EXPERIENCE REQUIRED:

• BS, or MS in science, engineering, or related field.
• Minimum 3-5 years’ quality role in FDA regulated cGMP environment.
• Extensive knowledge of GDP, cGMP, FDA Guidelines (such as 21CFR111).
• Excellent verbal and written communication skills, and a great team player.
• Excellent organization skills and attention to detail.
• Time management skill skills with a proven ability to meet deadlines.
• Proficient with Microsoft office (such as Word, Excel).
• Ability to learn quickly, work independently and function at high level.
• Professional quality certification or Lean Six Sigma training is a plus.
• Knowledge of RCA, risk management, understanding process control a plus.

Job Type: Full-time

Pay: $95,000.00 - $110,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee discount
• Health insurance
• Health savings account
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Supplemental Pay:

• Bonus pay

Ability to commute/relocate:

• Middletown, CT 06457: Reliably commute or willing to relocate with an employer-provided relocation package (Required)

Education:

• Bachelor's (Required)

Experience:

• FDA/ Regulated environment: 3 years (Required)

Work Location: One location