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Manufacturing Operations Specialist

2 months ago


Bethlehem, Pennsylvania, United States OraSure Full time
Job Summary

As a Manufacturing Support Specialist at OraSure Technologies, you will play a critical role in ensuring the quality and efficiency of our manufacturing processes. This position requires a strong understanding of GMP/ISO FDA regulated medical device facilities and the ability to work collaboratively with cross-functional teams to achieve set goals.

Key Responsibilities

• Review completed production BPRs for completeness and accuracy prior to QA Lot Release.
• Complete SAP transactions for labor hours and materials.
• Update metrics for presentation and distribution via department scorecards.
• Prepare quality documentation as needed (ie CTNs, PDRs, NCRs).
• Assist operations team with preparation activities for customer/regulatory audits.
• Perform special assignments as apparent or assigned.
• Plan, organize and monitor activities according to priorities.
• Communicate and collaborate with management and supervisory staff within manufacturing and quality to achieve set goals.

Requirements

• Three to five years of working experience in a related work environment.
• Experience in GMP/ISO FDA regulated medical device facility.
• Previous Manufacturing experience in an FDA regulated environment.
• The individual must have a working knowledge of the medical diagnostic industry and compliance regulations.

OraSure Technologies is an Equal Opportunity Employer

We are committed to ensuring equal employment opportunities for all. All employment decisions, policies and practices are in accordance with applicable federal, state and local anti-discrimination laws.