Job added in hotlist
Applied job
Contract job
90-day-old-job
part-time-job
Recruiter job
Employer job
Expanded search
Apply online not available
View more jobs in Campbell, CA
View more jobs in California

Job Details

Quality Control Specialist

Location
Campbell, CA

Apply for this job






Profile

**MEMBERS ONLY**SIGN UP NOW***. (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.


Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, womens health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.


Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.


Position Description

This position will be responsible for functioning as the Lead Analyst for the BSL QC group (Microbiology or Chemistry) and all associated support functions, ensuring that all Microbiology, Chemical, Potency and/or Biochemical testing is performed according to the FDA, Foreign MOH and Allergan requirements.

This individual will verify that the quality of drug substance product meets all Regulatory commitments, assist in the daily activities related to the product stability testing program, and manage routine communication with contract testing facilities. The individual will collaborate with and effectively represent QC in meetings with internal and external partner groups under the leadership of the QC Manager.


Main Areas of Responsibilities




  • Supervise and train in the areas of QC (Microbiology or Chemistry), compliance, and documentation preparation.


  • Responsible for writing, reviewing testing procedures, and streamlining same in order to increase lab efficiency.


  • This individual will serve as a technical resource representing QC during FDA and Ministry of Health inspections.


  • The individual will be responsible to ensure appropriate training and development plans are in place for all employees in the QC group.


  • The individual will be expected to lead and participate in continuous improvement activities within the Drug Substance Operations (DSO).


  • Implement, perform and coordinate all laboratory tests and review raw data and certificate of analysis for raw materials, in-process test data, and final product test results.


  • Perform Analytical and Microbiological testing as required.


  • Contribute to the review of SOPs. Prepare and/or revise SOPs as necessary. Authors SOPs.


  • Support performance qualification, validation studies and routine validation requirements.


  • Lead the BSL QC function to ensure all method transfers are completed in a timely phase appropriate compliant manner.











Requirements



  • Demonstrated knowledge and experience with validating QC methods.


  • Working knowledge of regulatory compliance and pre-clinical production of protein therapeutics and a thorough understanding of the integration of the two in clinical manufacturing. Experience working in a GMP environment. Familiarity with process characterization and process validation.


  • Demonstrated ability to manage, multi-task, delegate, and retain flexibility in a dynamic environment.


  • Well-developed written and oral communication skills. Motivated to work in a team environment.


  • Consistently deliver on commitments and respond to customers’ needs in a timely and courteous manner.


  • Demonstrated knowledge of the use of a continuous improvement methodology in a lab testing environment, desired but not essential


Education




  • MS in Chemistry/Biochemistry or a related Biological Science field with 4 years of relevant industrial experience or BS in Chemistry/Biochemistry or a related Biological Science field with 6 years of relevant industrial experience.

  • 3-5 years of experience within a technical environment














Company info

Sign Up Now - ChemistryCrossing.com

By using Employment Crossing, I was able to find a job that I was qualified for and a place that I wanted to work at.
Madison Currin - Greenville, NC
  • All we do is research jobs.
  • Our team of researchers, programmers, and analysts find you jobs from over 1,000 career pages and other sources
  • Our members get more interviews and jobs than people who use "public job boards"
Shoot for the moon. Even if you miss it, you will land among the stars.
ChemistryCrossing - #1 Job Aggregation and Private Job-Opening Research Service — The Most Quality Jobs Anywhere
ChemistryCrossing is the first job consolidation service in the employment industry to seek to include every job that exists in the world.
Copyright © 2018 ChemistryCrossing - All rights reserved. 21