Quality Assurance Associate. Job at Synaty Tech
Essential Duties And Responsibilities
- Provide support and oversight of environmental sampling/testing /reports, manufacturing, packaging, labels, material approval, and review of investigations.
- Review and update SOPs, policies and processes regularly to ensure all quality standards are compliance with cGMP standards, FDA and all competent authority regulations and requirements.
- Review and approve documents supporting manufacturing and development operations, including
- SOPs, QAPs, pre and post executed batch records, and deviation reports.
- Assist with client and regulatory audits.
- Perform internal quality audits in either a lead or team auditor role.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty. The
requirements listed below are representative of the knowledge, skill, and/or ability required.
- Bachelors degree in Science (BS/BA) from a four-year college or university preferred; or three (3) to five (5) years pharmaceutical or related experience and training; or equivalent combination of education and experience
- Thorough understanding of aseptic processing and technology, including US compliance and regulatory requirements, required; working knowledge of EU requirements desired.
- Knowledge with implementing cGMPs, FDA & DEA, US and EU Regulations.
- Demonstrated ability to work independently, handle multiple tasks simultaneously, negotiate and meet critical timelines, thorough attention to detail and strong organizational skills.
Job Type: Full-time
Pay: $10.48 - $42.55 per hour
Benefits:
- Health insurance
Schedule:
- Monday to Friday
Experience:
- Quality Assurance Associate.: 3 years (Preferred)
- Pharmaceutical: 2 years (Preferred)
- Knowledge with implementing cGMPs, FDA & DEA: 2 years (Preferred)
Work Location: One location
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