Research Associate, Bio Analytical Operations Job Summary
The Research Associate I, (Bio Analytical Operations) position performs activities required for reviewing clinical and non-clinical assay and study documentation in a GLP compliant environment. Responsibilities include, GLP documentation, report Quality Control, and interaction with the client's quality assurance unit. Job Responsibilities
Education & Qualifications
- Review assay documentation in support of GLP non-clinical and clinical studies.
- Review validation reports in support of GLP non-clinical and clinical studies.
- Review bioanalytical reports in support of GLP non-clinical and clinical studies.
- Ensure that documentation is compliant per SOP and regulatory guidelines.
- Interact with the client's Quality Assurance units(s) regarding data auditing.
- Provide support for inspection readiness.
- May support internal and external audits, including corrective actions as needed.
- Any other responsibilities required by management related to job functions.
- May assist with Data File Management, BAS Records Management, Controlled Documentation Management (e.g. SOPs),BAS Training Management.
- Preferred: Bachelor's or equivalent experience with GLP or GMP Documentation in a regulated lab environment.
- Preferred: At least 1-2 years of experience in a bioanalytical laboratory, research laboratory, or Biotechnology Company.
- Preferred: Documentation experience in a GLP or GMP compliant environment, or equivalent analytical experience in a regulated lab environment.
- Preferred: Experience with GLP or GMP documentation.
- Preferred: Excellent writing and verbal communications skills.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.