QUALITY ASSURANCE MANAGER jobs in Passaic, NJ

Quality Assurance Receiving Manager

JOB OVERVIEW

Multi-Pak Packaging is a trusted partner to leading companies in the healthcare industry. We provide clients with labeling and packaging options as well as comprehensive supply chain solutions.

Under the direction of the Director of Quality Control, the QA Receiving Manager ensures that products adhere to a defined set of quality standards and meet the requirements of customers.

Responsible for inspection of all incoming bulk, components, primary and secondary labeling, and other packaging operating supplies per appropriate specification and/or procedure to ensure adherence to cGMPs and other regulatory requirements. He/she shall ensure that all incoming material meets the required specifications to be released for production. He/she will lead the receiving specialists' team to ensure timely and effective processing of received materials.

RESPONSIBILITIES:

• Effectively monitoring and enforcing compliance with the company's SOPs and cGMPs.
• Manage the QA Receiving Specialists by distributingworkloads and establishing daily priorities.
• Responsible for training all QA Receiving Specialists and lead.

· Ensure inspection activities are being performed not limited to verifying the quantities of all the pallets received in, performing the sampling for receiving inspection, signing off the receiving inspection report and logging into the Receiving inspection logbook. The inspection shall be performed for every incoming material – bulk, labeling material and components.

· Ensure receiving reports are created and documented correctly as per the SOPs and work instructions and are consistent with the product description detailed in the Inventory Checklist.

· Assures material meets the appropriate specifications through appropriate inspection methods as described in the SOP and/or specification.

· Responsible for managing the entire label issuance procedure including the inspection, label verification against client specifications, issuance to the Label Room and verifying the returns from the production.

· Responsible for informing the Client Services department and required personnel of any receiving inspection discrepancies.

· Ensure the Transfer tags are created and documented correctly for the label transfers from Chapin warehouse to Clinton warehouse and vice versa.

· Ensure samples are correctly stored and managed in the Chapin warehouse.

· Manage the Quarantine area in both Chapin and Clinton warehouse.

· Responsible for verifying the disposition of materials and signing the documentation for the same.

· Responsible for maintaining accurate records and following good documentation practices for all materials inspected.

· Maintain and manage all Component Specifications and Color Standards as required and provided by the client.

• Review production schedule and set receiving priorities to ensure no delays in releasing materials to production.
• Actively participate in the daily production meetings and provide accurate material receipt and release information.

· Participate in the improvement process.

· Ensure that all allergen and certified (Gluten Free, Kosher, ect.) bulks are properly tagged.

· Investigating any production or inventory discrepancies when they arise.

· Assists in Quality Department with documentation and or as a QC Inspection when required.

· Verifying Finish Good quantity

· Assist with FDA and other regulatory agency inspections as needed.

· Backup and assist in all areas of Quality, on an as needed basis.

· Assist in inventory management.

QUALIFICATION REQUIREMENTS:

· Associate’s/Bachelor’s Degree (preferred).

· 5 years of related experience (especially in pharmaceutical industry).

· 3 years lead or supervisory experience.

· Ability to demonstrate strong organizational skills.

· Exercise judgment within defined procedures and practices.

· Must be a strong team player with good problem solving, and good verbal and written communication skills.

· Knowledge of GMP documentation and FDA required.

· General knowledge of quarantine and warehouse operation.

· Good knowledge of Microsoft Office programs.

• The person in this position is required to communicate with all other departments and must be able to exchange accurate information in these circumstances.

REPORTING RELATIONSHIP:

• Manager: Director of Quality Control • Managerial Responsibility: Yes

PHYSICAL/MENTAL DEMANDS:

• Must be able to lift-up to 30 pounds frequently and 50 pounds on occasion.
• Must be able to remain in the stationary position for up to 40% of the time.
• Must be able to walk or stand up to 95% of the time.
• The person in this position will need to occasionally move about inside the office to access office machinery, filing cabinets, etc.
• The person in this position will need to frequently move about inside the warehouse requiring them to position themselves through pallets and warehouse locations.
• The person in this position is required to function in narrow aisles or passageways.
• The person in this position will need to occasionally kneel, climb, crawl, climb and/or reach to perform inspections.

Job Type: Full-time

Pay: $50,000.00 - $55,000.00 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
• Overtime
• Weekends as needed

Ability to Relocate:

• West Caldwell, NJ: Relocate before starting work (Required)

Work Location: In person