QMS Document Control Owner

Be part of something altogether lifechanging!

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake lifesaving activities ranging from fundamental biological research to developing innovative vaccines new medicines and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us working on challenges that truly matter with people that care for each other our customers and their patients. With associates across 40 countries Cytiva is a place where every day is a learning opportunity so you can grow your career and expand your skills in the long term.

Forming part of the Biotechnology segment at Danaher we bring together dedicated technical expertise and talent to develop the next generation of lifechanging therapeutics.

The QMS Document Control Owner for Cytiva is responsible for the administration of documents in the electronic QMS and PLM systems. Performs evaluation of internal controls and maintenance of documentation as related to compliance with internal and external quality and regulatory standards. Assist with the implementation of standard operating procedures to define and improve quality system functions

This position is part of the Quality Assurance Department located in Pensacola Florida and will be onsite At Cytiva our vision is to advance future therapeutics from discovery to delivery.

In this role you will have the opportunity to:

• Collaborate with crossfunctional teams (internal and external) to establish and maintain document controls that align with applicable regulatory requirements. Ensure compliance with documentation requirements defined in ISO 9001 ISO 14000and OSHA PSM and other international guidelines as appropriate.
• Ensure compliance throughout the document/record lifecycle: including the creation approval issuance revision retention timely retrieval during audits and obsoletion.
• Provide oversight of the document periodic review program ensure status is conveyed to internal stakeholders and monitors related KPI.
• Support the Document Control Review by tracking requested revisions and ensuring internal teams are apprised of changes and that implementation dates are met.
• Proactively identify opportunities for process improvements automation and efficiency gains in the document control function.

The essential requirements of the job include:

• Bachelors Degree required; life science related field preferred with 3 years or AA degree with 5 years of relevant experience in document control/record control
• SOP/Work Instruction experience with document control management and product lifecycle management systems in biotech pharma drug product or medical device document control experience preferred
• Strong foundational knowledge in current Good Manufacturing Practice (cGMP) and Good Documentation Practice (GDP)
• Highly skilled in Microsoft Word for comparing and merging documents creating and using templates creating form using fields and using advance formatting built in styles.
• ISO requirement experience

It would be a plus if you also possess previous experience in:

• Strong interpersonal and communications skills
• Experience with Veeva & Magic systems

We offer comprehensive package of benefits including paid time off medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

Join our winning team today. Together well accelerate the reallife impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

For more information visit www.danaher.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race color national origin religion sex age marital status disability veteran status sexual orientation gender identity or other characteristics protected by law. We value diversity and the existence of similarities and differences both visible and not found in our workforce workplace and throughout the markets we serve. Our associates customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform crucial job functions and to receive other benefits and privileges of employment. Please contact us at to request accommodation.