QC Document Control Specialist

bioMérieux • Hazelwood, MO

6d • $23 - $34

About The Position

This role acts as a document specialist and administrative support for the Final QC and Quality Assurance departments. Responsible for following Good Documentation Practices. Ensures that quality documentation meets applicable customer, regulatory, and Company requirements. Ability to understand manufacturing specifications, requirements, procedures and departmental processes. Performs all duties using safety conscious and cGMP practices.

Requirements

• High School Diploma, GED or equivalent and 5+ years experience of document review in a Quality /GMP environment (medical device preferred), including strong computer skills such as Microsoft Office Package (Excel, Word, etc.).
• Experience in cGMP document management systems and/or change management systems is preferred.
• Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
• Written Communications - including the ability to communicate technical data in written form
• Troubleshooting issues to identify and resolve problems efficiently
• Priority setting that align with business objectives
• Informing others by sharing clear, timely information to ensure alignment.
• Build and maintain positive, productive interactions with colleagues
• Must be able to demonstrate flexibility in responding to unexpected demands
• Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel, applies skills independently in most situations; handles moderately complex tasks with occasional guidance
• Ability to remain in stationary position, often standing, for prolonged periods.
• Ability to wear PPE correctly most of the day.
• Ability to adjust or move objects up to 50 pounds in all directions.

Nice To Haves

• Experience with Trackwise Digital and SAP is a plus

Responsibilities

• Collaborate with cross-functional departments to ensure timely implementation of change controls
• Responsible for facilitating procedure updates with process owners.
• Route documents for review, approval and assure completion of the approval process.
• Reviews and distributes documents and correspondence.
• Performs data entry and prepares a variety of documents, related to quality system records
• Organizes meetings and/or appointments.
• Reasonable, reliable attendance and punctuality is an essential job function required for this position.
• Supports QC and other projects as requested by management.
• Perform all work in compliance with company quality procedures and standards.
• Perform other duties as assigned.

Benefits

• A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
• Company-Provided Life and Accidental Death Insurance
• Short and Long-Term Disability Insurance
• Retirement Plan including a generous non-discretionary employer contribution and employer match.
• Adoption Assistance
• Wellness Programs
• Employee Assistance Program
• Commuter Benefits
• Various voluntary benefit offerings
• Discount programs
• Parental leaves

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees