QC LC/MS Analyst

Location
Colorado Springs, Colorado
Salary
Competitive
Posted
Dec 06, 2017
Closes
Jan 06, 2018
Ref
18043768
Contract Type
Full Time
Date Posted: 04/Dec/17



Requisition:



Job Title: QC LC/MS Analyst



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 .



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 NASD is looking to add an LC/MS Quality Control (QC) Analyst to their high-performance manufacturing team working at the state-of-the-art, contract API manufacturing facility that specializes in Nucleic Acid Chemistries located in Boulder, Colorado.



The QC LC/MS Analyst will perform activities assigned to the group including analyzing in-process manufacturing samples, release samples and stability samples for sequencing, related impurities and identity by LC/MS in the analytical chemistry Quality Control laboratory. This position will support basic QC functions in the absence of LC/MS samples.



This position is for the M-F day shift (8:00 am to 5:00 pm)and will perform testing according to established procedures and analytical methods. This position is required to document results according to Good Documentation Practices (GDP)in compliance with current Good Manufacturing Practices (cGMP). The position will perform these activities in a regulated environment governed by FDA and other international regulatory agencies.



- Performs activities assigned to the QC lab including testing, write up and review.



- Identifies issues and elevates appropriately to QC management to determine appropriate action.



- Meets regularly with work team, team coordinator and team manager to distribute work to meet priorities.



- Follows Agilent Standard Operating Procedures (SOPs), analytical methods and other guiding documents to execute testing, write up and review.



- Works effectively individually and as part of a high performing work team and exercises judgment when escalating issues to team coordinator and QC Management.



- Documents results according to Good Documentation Practices and participates in investigations into anomalous results for QC related deviations, inquiries/investigations, and corrective / preventative actions (CAPAs)as required.



- Will be directly involved in client Audits and regulatory inspections and is expected to act appropriately.



Qualifications:

- 3+years of relevant LC/MS industry experience.



- 3+ years of cGMP experience required



- A Bachelor's degree (B.S.) or equivalent experience;may consider combination of training,education, and experience.



- Knowledge of cGMP and USP guidelines as well as international regulations (i.e., International Committee on Harmonization (ICH)) pertaining to QC programs that support production of APIs.



- Ability to follow protocols, assist in writing reports and assist in revising procedures and methods.



- Experience performing analytical methods in a QC environment.



- Experience with LC/ MS, HPLC, UV, Karl Fisher Moisture, pH, Osmolality, GC, ICP/MS, LC/MS, GC and or GC/MS



- Knowledge of and skill in using chromatography data systems and basic computer software and hardware applications, including Microsoft Word and Excel.



- Outstanding written and oral communication skills.



- Ability to multi-task and manage various projects and competing priorities: must be able to use individual discretion in completing work assignments, assists the group in establishing priorities, setting standards and working collectively to meet project deadlines and objectives.



While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to sit. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 50 pounds.



While performing the duties of this job, the employee is frequently exposed to toxic or caustic chemicals. The employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, and explosives. The noise level in the work environment is usually moderate.



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.



For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster available here:









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 contact +1- (US and Canada only) or email . EOE AA M/F/Vet/Disability.



Company:



Business: Diagnostics and Genomics Group



Job Category: Quality/Regulatory



Job Sub-Category: Quality Control Analyst



Region: Americas



Country or Area: United States



State/Province: Colorado



Town/City:



Shift: Day Job



Job Type: Experienced



Schedule: Full-time



Travel Required: No



Duration

(Temp Positions Only): Not applicable



HR Country Location: United States



HR Town/City Location : Boulder