Celgene Senior Analyst, QC Chemistry in Phoenix, Arizona
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Purpose and Scope of Position
The Sr. Analyst, QC Chemistry, is responsible for routine analysis of in-process, finished product, raw material and stability samples to ensure that samples meet required specifications. The Sr.Analyst is also responsible for peer review, training, supporting document management, projects,CAPAs, and investigations to ensure the laboratory remains in compliance throughout testing, improvement, and correction lifecycles.
Required Competencies: Knowledge, Skills, and Abilities
Advanced PC skills
Advanced math skills
Advanced written and verbal communication skills.
Advanced proficiency in Microsoft Word, Outlook, and Excel.
Intermediate knowledge of electronic document management systems.
Advanced GMP documentation skills.
Strong attention to detail.
Advanced knowledge of laboratory safety practices.
Advanced knowledge of relevant scientific and technical principles.
Advanced knowledge of analytical techniques, software, and/or equipment.
Ability to use instrumentation and instrument software, including but not limited to TOC, HPLC/GC, Conductivity meter, and PSA.
Ability to perform wet chemistry tests, including but not limited to titrations, ROI and pH
Ability to use PPE effectively.
Ability to mentor peers on day-to-day tasks and more technical tasks; cooperative and works well with a team.
Ability to communicate effectively with peers (department, cross-functional, and management).
Basic project management skills; capable of leading departmental teams.
Ability to develop detailed instructions accurately.
Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements; uses good judgment and follows procedures.
Ability to interpret/write technical documents.
Advanced knowledge of cGMP, OSHA, DEA, USP, EP, and JP; ability to deal appropriately with regulatory agencies.
Ability to make formal presentations to internal and external audiences.
Ability to train other analysts on a wide variety of tasks.
Willingness to learn and share knowledge.
Capable of independent problem-solving; informs management as appropriate.
Strong critical thinking skills.
Intermediate knowledge of processes and instrumentation.
Ability to work under limited supervision.
Demonstrates strong personal organizational skills.
Ability to pass an initial full physical with annual monitoring.
Duties and Responsibilities
Perform testing of raw material, in-process, finished product and stability samples.
Perform various wet chemistry and analytical chemistry methods.
Follow methods and procedures, with strict adherence to cGMP documentation requirements.
Anticipate and troubleshoot problems.
Recommend corrective actions and participate in development of best practices.
Complete all work assigned in a timely manner.
Work and communicate effectively within the team to ensure timelines are met.
Perform peer review of testing data.
Review all data in accordance with applicable procedures and cGMP requirements.
Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
Complete all review in accordance with required release timelines.
Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.
Train new analysts to general job duties.
Complete necessary training to become a qualified trainer.
Perform training effectively.
Document training per procedural and cGMP requirements.
Support document revision, project, CAPA, and investigation/deviation tasks.
Perform assigned tasks within a CAPA, deviation, or project
Participate in more complex projects and continuous improvement efforts.
Take a leadership role in some projects.
Draft and review technical documents, such as SOPs and protocols.
Communicate effectively with management regarding task completion, roadblocks, and needs.
Demonstrate initiative, courage, and continuous improvement throughout
Support lab operations by completing other tasks associated with testing.
Prepare various solutions needed to support method performance; for example, mobile phase,needle wash, etc.
Participate in housekeeping performance and audits.
Review status of supplies and reagents to ensure items are ordered as needed.
Perform other tasks as assigned
Education and Experience
Bachelor’s degree preferred.
3 years relevant work experience required, preferably in a regulated industry.
An equivalent combination or education and experience may substitute.
This position requires regular medical surveillance and may require incumbent to wear a
respirator or gown.
The incumbent must be able to distinguish colors and possess correctable vision to 20/20,
annual eye exam is required.
The incumbent must analyze numerical values on a daily basis.
The incumbent will be working a laboratory setting up to 6 hours per day.
The incumbent will occasionally be working around hazardous materials to include chemical
agents up to 6 hours per day.
The incumbent often works for extended periods alone, up to 8 hours per shift.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
Senior Analyst, QC Chemistry
Location: Phoenix, AZ, US
Job ID: 17000503