This site uses cookies. To find out more, see our Cookies Policy

Scientist in Santa Monica, CA at Apex Life Sciences

Date Posted: 12/12/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    12/12/2018
  • Job ID:
    913707

Job Description


A well-regarded company focusing on patient therapies is seeking Senior QC Specialist to join their team. This is a great opportunity to work for an industry leader!

DUTIES & RESPONSIBILITIES:

  • Provide technical support for assay performance and troubleshooting of analytical issues in the context of a GMP laboratory.
  • Perform analytical testing in support of in-process, lot release, and stability.
  • Represent Clinical QC as a primary point of contact for analytical methods in collaboration with Manufacturing and Analytical Development organizations.
  • Represent Clinical QC on Product Quality Teams and to other stakeholders.
  • Author and revise processes and procedures for analytical method and associated work streams.
  • Establish processes and procedures for purchasing, implementation, training and maintaining QC equipment in collaboration with method subject matter experts
  • Coordinate with stakeholders for equipment validation and manage validation activities in alignment with established timelines
  • Responsibility for ensuring electronic data meets Part 11 requirements in alignment with internal procedures
  • Lead teams to support deviations, investigations, CAPAs and change control activities as needed
  • Identify and lead teams for lean improvement activities
  • Support inspection readiness activities 
  • Participate in generating training module and instruction led training material
  • Other duties as required


QUALIFICATIONS

  • Ph.D. and 5 years of experience, preferably in a GMP environment OR Master’s degree with at least 7 years of experience, preferably in a GMP environment OR Bachelor’s degree with at least 9 years of experience, preferably in a GMP environment
  • Experience with flow cytometry, cell-based bioassays, and ELISA methodologies
  • Experience with method qualification and transfer activities
  • Experience in performing equipment validation activities
  • Familiarity with FDA, ICH and GMP guidelines
  • Familiarity with Part 11 requirements
  • Ability to think critically and demonstrate troubleshooting/problem solving skills
  • Experience in conducting lab investigations, writing deviations, implementing CAPAs and initiating change controls
  • Excellent skills in Microsoft Office, data analysis software, and other related applications
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

Please send resumes to khurlbut@apexlifesciences.com 

#LI-KH2

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




913707