QC Document Control Specialist

Position Summary

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.

Primary duties

• 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.

Qualifications

This role requires 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. Experience with Trackwise Digital and SAP is a plus

Knowledge, Skills, and Abilities

• Consistently upholds and reflects the core ethical principles and values that bioMerieux 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

Working Condition

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.

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMerieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [emailprotected].

BioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at (385) 770-1132, by email at [emailprotected], or by dialing 711 for access to Telecommunications Relay Services (TRS).