Quality Assurance Assistant

Quality Assurance Assistant position is available at Sciecure Pharma Inc. Sciecure develops and manufactures Solid Oral Dose tablets and capsules. We are seeking an QA Assistant on a full-time basis. Considering local candidates with Record keeping experience or GMP experience and an interest in Quality Assurance. A background in Chemistry or Pharmaceutical studies is a plus.

Must be proficient in reading, writing, and translating documents in Mandarin.

Primary Responsibilities:

Assists project teams in multiple functional areas throughout the company in completing controlled documents in a timely manner to meet project deadlines.
Facilitate and track drug manufacturing document reviews and approvals, to ensure FDA compliance.
Assist in Batch Record Review for Chinese Manufacturing sites.
Audit internal processes for Quality Assurance and Regulatory requirements.
Review GMP QC laboratory records, notebooks and documents to ensure compliance with internal procedures, cGMP, and other regulatory requirements.
To become proficient in Quality Assurance procedures and responsibilities.
Qualifications:
Applicant must be a US Citizen or legally eligible to work in the United States under the Immigration Reform and Control Act.
Proficiency in Chinese is required.
Bachelor’s degree in science or equivalent is required, with studies in Biology, Chemistry or Pharmaceutical Science.
Interest in FDA guidelines, cGMP’s, quality improvement process.
Prior work or studies in the areas of Biotechnology or Pharmaceuticals is a plus.
Submit summary of transcripts with relevant college courses
Good written and verbal communication skills.
Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a timeline-driven environment.
Must be proficient with MS Office applications.
Job Type: Full-time