Quality Assurance Specialist - Regulatory / Compliance (Up $3500, Entry Level) - #1111748

Up to $3.5k + bonuses

Entry Level into Lab / Biopharma / Clinical Research Testing

Perm Employment

Job Details

• Working hours: Office Hours

• Location: East 

Job Descriptions

• Responsible for assisting / performing facility, process, vendor and local validation activities to assure compliance with applicable federal, state, and local regulations as well as corporate policies, Good Manufacturing Practice (GMP), applicable ISO requirements and Standard Operating Procedures (SOP).

• Understand the voice of the customer and participate in identifying recommendations to the Quality Management. Assist in executing continuous improvement initiatives as supported by QMS metrics and/or site management

• Perform internal and vendor audits, and review quality records to ensure compliance with regulations and corporate policies.

• Analyze quality system metrics and participate in continuous improvement initiatives and management reviews.

• Support regulatory inspections and client audits by preparing files and assisting with responses to findings.

• Review and approve critical documents like SOPs, protocols, and reports for accuracy and compliance.

• Provide regulatory support to operations and customers, including basic training and responding to inquiries.

Requirements

• Degree in Life Science or Biotechnology or equivalent

• Prior experience (1-2 years) Quality System & Assurance or GMP / GLP will be advantageous

*Interested applicants, please apply with your resume with reason(s) for leaving previous employment(s), notice period, last drawn and expected salary.

All applications will be treated with strictest confidentiality. We regret that only shortlisted candidates will be notified. 

RecruitFirst Pte Ltd E.A. 13C6342

Joseph Yap Shi Hao (R1767577)