Manufacturing Operations Investigator

Job Description

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 innovative, contract API manufacturing facility that specializes in Nucleic Acid Chemistries located in Frederick, Colorado.

The Manufacturing Operations Investigator / Technical Writer provides technical writing and compliance expertise and will be responsible for the following activities:

• Lead investigation activities by gathering information from internal and external sources to resolve 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 lead change controls and CAPAs

• Participate in customer and regulatory meetings and audits/inspections

Duties & Responsibilities:

Deviation Investigation and CAPA:

• Thoroughly investigate deviation events using root cause analysis techniques. Applies technical writing strategies to ensure content is clear, concise, and complete. Lead team to evaluate pertinent aspects involved in resolving 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 handle change controls as needed 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.

Qualifications

• Bachelor's or Master's Degree or equivalent

• Post-graduate, certification and/or license may be required

• 4+ years experience for entry into this level

• Prior experience and/or training working in a GMP manufacturing environment is helpful

• 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

• Knowledge of and skill in using computer software and hardware applications, including Microsoft products are required

• Advanced computer skills, especially with Microsoft Word is helpful

• Ability to lead various projects; must be able to use individual discretion in completing work assignments; while assisting the group in prioritizing, 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

#LI-DT1

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.

Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@agilent.com or contact +1-262-754-5030.

For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

Pay Range

$87,600.00-$136,875.00

The salary range for this position may differ based on your actual work location.

Eligible for Company Car

No

Benefits in Brief

Travel Required

Occasional

Schedule

Schedule:Full time

Shift

Day

Duration

No End Date

Job Function

Quality/Regulatory