Quality Batch Release Specialist

About the role

Under general supervision, the Quality Assurance Batch Release Specialist is responsible for ensuring the compliance of all batch records and release of products for operations and shipments. The Quality Specialist also coordinates with internal teams and external labs to ensure batch record information for accuracy and legibility per current good manufacturing processes.

Responsibilities

• Ensures compliance with cGMP, Company SOPs and FDA requirements during all phases of operations.
• Issuance, assembly and auditing of batch records to assure all regulatory and internal requirements for the product quality.
• Completes final review of batch records prior to release of product.
• Creates certificates of analysis.
• Reviews all batch records for compliance and acceptance.
• Ensures corrections to batch records and completion.
• Coordinates with quality inspectors and production teams daily for GDP compliance of documentation.
• Releases Bulk for operations including documentation and system transactions as assigned.
• Releases Finished Good products for shipment including documentation and system transactions.
• Communicates with Clients and Customer Quality regarding product record discrepancies and release status.
• Maintains metrics and data, as required, for Quality.
• Provides backup support for Quality Inspections in filling and compounding, as needed.
• Other duties, as assigned, by the manager.

Qualifications

Required Education, Certification & Experience: Bachelor Degree, or equivalent work experience. 1-2 years of experience in FDA regulated business. 1-2 years GDP Experience/Training

• Knowledge of ISO 13485 and or ISO 9001
• Knowledge of QSR for Medical Devices
• Knowledge of cGMPs; ability to understanding of good documentation practices
• Ability to effectively communicate both verbally and in writing (English)
• Computer skills; organizational skills
• Ability to perform work via MS Office applications (Excel and Word)
• Attention to detail with ability to comprehend and process technical information.
• Advanced problem solving and decision-making.

Physical Demands

Be able to lift a minimum of 50 pounds. Be able to push or pull heavy objects up to 250 pounds, if required for assigned tasks. Be able to work 8 - 12 hours shifts. Perform repetitive tasks. Routinely stand, sit, hear, walk, and talk. Reach, climb, bend, kneel, crouch, twist and balance; sometimes in awkward or tight spaces. Have good close vision, depth perception, and the ability to focus

Benefits

At Mativ, our benefits reflect how much we value and care for each other. We know that employees and their families have unique needs, so our comprehensive benefits offer flexibility, quality, and affordability.

• Medical, dental and vision insurance
• Consumer-Driven Health Plan (CDHP)
• Preferred Provider Organization (PPO)
• Exclusive Provider Organization (EPO)
• Company-paid basic life insurance and Additional voluntary life coverage
• Paid vacation and competitive personal time off
• 401(k) savings plan with company match
• Employee assistance programs – available 24/7 to you and your family
• Wellness and Work Life Support - career development and educational assistance