Quality Control Microbiology Analyst Associate (Day Shift) Frederick

Job Description

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.

Job Description:

Conducts routine, non-routine analysis and review to support release, stability testing, Environmental Monitoring, Cleaning Verification per Standard Operating Procedures (SOP) and Analytical Methods in accordance with current Good Manufacturing Practices (cGMPs) and regulatory requirements. Has a clear understanding of Good Laboratory Practices (GLPs), cGMPS, and other regulatory requirements. Effectively engages in continuous improvement of processes and procedures. Proven track record to exercise judgment and appropriately raises issues to QC management.

Essential duties and responsibilities:

• Outstanding communication skills, both written and oral, and will be expected to communicate directly with project managers and management.

• Conducts analysis associated with clinical and commercial under current Good Manufacturing Practices (GMP) regulations and guidance per Food and Drug Administration (FDA) and Organization for Economic Co-Operations and Development (OECD) as well as International regulations.

• Performs analysis on APIs (developmental and commercial), final product and other requested testing as per written procedures.

• Reviews data for compliance to specifications and reports and troubleshoots abnormalities.

• Ensures equipment is performing well and communicates and takes appropriate action as necessary.

• Required to follow good documentation practices.

• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

SHIFT: DAY SHIFT Monday - Friday

Qualifications

• Typically, 1-2 years of proven experience for entry to this level preferred

• Bachelor's degree (B.S.) or equivalent experience in Microbiology or related life sciences field with one to three years related experience and/or training; or equivalent combination of education and experience.

• Proven knowledge of cGMP guidelines, international regulations (i.e., International Committee on Harmonization (ICH) Q7) pertaining to Quality Control programs that support production of APIs, stability and drug product release is preferred.

• Demonstrated knowledge of analytical equipment and instrumentation, experience working in a GMP environment is preferred.

• Knowledge of FDA regulations and guidelines is preferred.

• Proven skills in coordinating and managing day to day tasks and working in collaboration to accomplish deadlines and objectives.

• Leadership skills and fosters working in a team environment.

• Works cross functionally to complete projects and testing.

• Knowledge of and skills in using computer software and hardware applications, including Microsoft Word and Excel

Familiar with the following laboratory disciplines is highly desired:

• Bacterial Endotoxin (LAL Analysis)

• Bioburden (Membrane Filtration Analysis)

• Total Organic Carbon (TOC Testing)

• Compressed Gas Monitoring

• Environmental Monitoring

• UV Analysis

• USP <61>

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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 see all of our notices for EEO below.

Pay Range

$50,040.00-$78,188.00

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