What are the responsibilities and job description for the QC Specialist I (life sciences) position at Alliance Pharma?
Job responsibilities:
· Learn and review documents against regulatory requirements; GLP, GCP, EPA, OECD, 21CFR Part 11
· Verify lab tasks are performed in accordance with Good Documentation Practices (GDP)
· Review laboratory documents and notebooks (e.g., plans, experiment/sample runs, chromatograms, instrument logs, etc.) for compliance to SOPs and applicable regulations
· Learn to identify non-compliance and deviations
· Review sample analysis documents for compliance to validated/qualified methods
· Verify run pass/fail
· Follow applicable SOPs and procedural documents
· Review data result files, validation data files, and reports
· Learn to prepare and submit study data to archives
· Escalate data integrity and non-compliance issues to Management
· Enforce lab safety SOPs and requirements
· Review system audit trails
· Other tasks as assigned
Education, Skills & Qualifications:
· BA/BS or higher; all experiences will be evaluated
· Able to learn regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP
· Able to review detailed data and documents
· Able to work effectively and contribute within a team
· Able to work with computer systems; able to document and communicate clearly
Job Type: Full-time
Pay: $47,000.00 - $54,000.00 per year
Schedule:
- Monday to Friday
Ability to Commute:
- Malvern, PA 19355 (Required)
Work Location: In person
Salary : $47,000 - $54,000