About

JOB PURPOSE

Under the supervision of the Quality Assurance Supervisor, this person is responsible for performing field QA activities: in process checks in the aseptic processing area, approval for area clearance, AQL inspection for finished products, retention sampling for finished products, batch record review, final product release, review and approve operation documents and forms, and approval / rejection of in-coming raw materials, components, and final product labels.

Ensure compliance of operations personnel with the company’s procedures and Good Manufacturing Practices (GMPs).

This position will also be responsible for identifying any deviations or non-conformances, writing deviation reports, performing root cause analysis, writing/revising standard operating procedures and forms, and tracking metrics, when required

KEY ACCOUNTABILITIES

• Regular and predictable onsite attendance and punctuality.
• Perform monitoring of Compounding in the aseptic processing area.
• Perform AQL inspection for Finished products
• Perform in-coming raw material, component, and labeling inspection and release.
• Review executed batch records to ensure compliance with approved procedures, and communicate and resolve discrepancies with manufacturing operators and supervisors.
• Provide Quality support to Manufacturing personnel on the floor – providing guidance during GMP events and initiation of deviations and investigations.
• Lead small scope projects, as assigned.
• Prepare and/or revise SOPs to ensure compliance with regulations and current practices. Keep current with regulations and industry best practices and update SOPs to improve compliance.
• Prepare all necessary reports in a timely manner to meet compliance requirements and business needs.
• Participate in Process Validation activities, including protocol execution and reporting, as necessary.
• Working knowledge of FDA regulations and application of GMPs.

QUALIFICATIONS

• Minimum: Bachelor’s degree in relevant science or engineering discipline.
• Preferred: The qualified candidate must possess a strong background in Quality Assurance, Quality Compliance and Quality Systems.

EXPERIENCE

Minimum:

• 4+ years of relevant cGMP experience.
• Hands-on experience with batch record review and product disposition.
• Hands-on experience with ERP, Documentation, and LIMS systems.

Preferred:

• Experience in a 503B Compounding manufacturing environment.
• Experience in FDA/EMA regulations in biopharmaceuticals or sterile injectable manufacturing is preferred.
• Work in an aseptic processing environment.
• Experience with use of complex research techniques and methodologies like six sigma and Kaizen to improve process/product quality.

SKILLS

• Strong written and verbal skills.
• Demonstrated effectiveness in task completion, decision making, and problem solving
• Excellent writing and computer skills and ability to present data in a logical manner.
• Excellent interpersonal and communication skills.
• Excellent organization and time management skills.
• Ability to work in a high-paced team environment.
• Working knowledge of FDA regulations, application of GMPs.

Job Type: Full-time

Pay: $70,000.00 - $75,000.00 per year

Benefits:

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

Education:

• Bachelor's (Required)

Ability to Commute:

• Dayton, NJ 08810 (Required)

Work Location: In person