This information is for internals only. Please do not share outside of the organization.
Your Role:
Perform analytical testing of cGMP materials (samples, reference standards) and ensure accuracy and quality of data by using proper laboratory techniques and documentation
Assist with training of newer laboratory staff as needed
Performs peer review
Work in a safe manner and ensure the lab stays in an audit ready and clean state
Maintain the laboratory by ordering reagents or supplies, ensuring clean glassware is available, disposing of waste properly, and completing general housekeeping chores
Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
Exercise judgment within generally defined procedures and practices
Solve problems and make decisions with minimal assistance
Maintain projects and timelines with minimal oversight
Meet with internal project groups to keep projects on track
Perform instrument Performance Verifications (PV) as needed
Manage assigned change controls and CAPAs to ensure on-time completion
Participate in OOS and OOT investigations via testing, good documentation, and assisting with identification of root causes
Assist with writing and revision of SOPs including raw material specifications, intermediate specifications, final product specifications, and stability protocols
Work cooperatively within the QC department and with other departments to achieve project goals
Work in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210, and 211 as applicable
Support all data integrity initiatives and strive for right first time
Who You Are:
Minimum Qualifications:
Bachelor's Degree in Chemistry, Biology or other Life Science discipline
3+ years' experience in a GLP or cGMP analytical laboratory environment
Preferred Qualifications:
Understanding of 21 CFR Part 11, 210 and 211, and ICH Q7
Strong attention to details, communication skills both oral and written
Knowledge and understanding of analytical chemistry techniques
Perform work in analytical testing lab with hazardous and toxic chemicals
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
