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Manufacturing Operations Investigator
Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.
The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in 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, lifesaving 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 Boulder, Colorado.
Manufacturing Operations Investigator / Technical Writer provides technical writing and compliance expertise within the Manufacturing Operations department. The role is responsible for the following activities:
* Lead investigation activities by gathering information from internal and external sources to determine root cause, evaluate product and equipment impact, evaluate 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 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.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
* Bachelor's degree or equivalent in a science-related field and/ or equivalent combination of education and experience. * 4+ years of related professional experience preferred. * Prior experience and/or training working in a GMP manufacturing environment is highly desired. * Knowledge of GMP guidelines as well as international regulations pertaining to the production of APIs and drug products. * Knowledge and understanding of the oligonucleotide manufacturing or related pharmaceutical manufacturing processes preferred. * Knowledge and experience authoring new facility and equipment SOPs using design documents and equipment manuals. * Knowledge and experience with various root cause analysis methodology required. *Skill in communication, written and verbal. Ability to lead cross-functional teams. Ability to interface with clients and regulatory agencies as required. * Knowledge of and skill in using computer software and hardware applications, including Microsoft products are required. Advanced computer skills, especially with Microsoft Word is preferred. * 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.
Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.
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