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The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in the capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life-changing, life-saving medicines.
Agilent Technologies Life Sciences Chemical Analysis business is looking to add an Operations Investigator / Technical Writer to their high-performance manufacturing operations team working at the new state-of-the-art, contract API manufacturing facility that specializes in Nucleic Acid Chemistries located in Frederick, Colorado.
In this role you will:
- Manufacturing Operations Investigator / Technical Writer provides technical writing and compliance expertise within the Manufacturing Operations department.
- Lead investigation activities by gathering information from internal and external sources to determine root cause, evaluate product and equipment impact, evaluate the risk to previous or future batches and develop effective CAPAs.
- Author comprehensive investigation reports
- Author and revise technical documentation including facility and equipment SOPs.
- Author and manage change controls and CAPAs.
- Participate in customer and regulatory meetings and audits/inspections
Essential Duties & Responsibilities:
Deviation Investigation and CAPA:Thoroughly investigate deviation events utilizing root cause analysis techniques. Utilizes technical writing strategies to ensure content is clear, concise, and complete. Lead team to evaluate pertinent aspects involved in determining deviation scope, root cause and impact. Identify necessary CAPAs to address root cause and contributing causes discovered during the investigation.
Change Control Management and Document Revisions:
Write and manage change controls as necessary to implement changes to documentation and SOPs to facilitate improvements driven by the deviation, CAPA and compliance inspection systems.
Customer and Regulatory Support:
Responsible for maintaining compliance and inspection readiness within the Operations department in the following ways:
- Complete deviations, CAPAs, change controls, document revisions and training activities to meet quality system requirements and timelines.
- Represent deviations, CAPA, and change controls during customer meetings and customer/regulatory inspections.
Skills and knowledge needed to be successful in this role:
- Skill in communication, written and verbal. Ability to lead cross-functional teams. Ability to interface with clients and regulatory agencies as required.
- Skill in managing various projects; must be able to use individual discretion in completing work assignments; while assisting the group in establishing priorities, setting standards and working collectively to accomplish deadlines and objectives.
- Ability to read, analyze, and interpret industry-related periodicals, SOPs, and government regulations.
- Ability to write technical reports, business correspondence, and procedures.
- Ability to respond to common inquiries or complaints from customers, co-workers, subordinates, and supervisors regarding the products and processes.