Forecyte Bio Limited
7495 New Horizon Way, Suite 130-150, Frederick，MD 21703
Tel.: +1 215-589-3593
177 Yiwei Road, Pilot free trade zone, Shanghai, China
Tel.：+86 21 80438700
The Quality Assurance Associate is responsible for performing various tasks within the department of Quality Assurance in accordance with current Good Manufacturing Practices (cGMP).
Key responsibilities and roles (including but not limited to):
• Liaise with the Production team for the review of executed Production Records
• QA on the floor to support manufacturing
• Review SOPs, logbooks, and other documentation related to daily QA activities.
• Perform internal audits of GMP operations
• Provide support for external regulatory or partner GMP audits
• Develop and implement enhancements to the quality system procedures
• Other duties as assigned
• Bachelor’s Degree in a relevant discipline (e.g., chemistry, biological sciences, engineering, etc.) with 0-1 years of QA experience in the pharmaceutical bio industry (recent grad ok)
• Effective communication (verbal and written), interpersonal, and teamwork skills
• An ability to be productive and successful in an intense work environment
Additional Preferred Capabilities
• Previous experience in CDMO industries is desirable.
• Experience in working with GMP compliant/quality-controlled procedures is desirable
• Multilingual (English and Chinese)
Company offers competitive benefits in the industry including 401(k), 401(k) matching, Dental insurance, Flexible schedule, Flexible spending account, Health insurance, Health savings account, Life insurance, Paid time off, Referral program, Vision insurance
Supplemental Pay: Bonus pay