job summary: Job Title:
Quality Assurance Auditor
This person will work in the Quality Assurance Department to conduct internal audits and review all activities at facility, identifying any cGMP or quality deficiencies. He/She will closely interact with the Manufacturing Department to audit all paperwork involved with the manufacturing, and processing operations of a drug product and provide batch record related metrics as required.
location: Cranbury, New Jersey
job type: Permanent
salary: $50,000 - 60,000 per year
work hours: 9 to 5
- Review all activities occurring within the company, identifying any cGMP or Quality deficiencies in Manufacturing, Warehouse, calibrations, Materials processes, Engineering, Facilities, QA, contractor, or validation systems.
- Audit all paperwork involved with the manufacturing and processing operations of a drug product.
- Review batch records for accuracy and completeness to ensure proper procedures were followed. Follow-up with various departments to expedite releases.
- Monitor production operations for cGMP compliance.
- Write QA related SOPs and conduct cGMP/SOP training sessions.
- Conduct internal audits and monitor facility through walk -thru assessments.
- Issue facility logs and labeling as required.
- Perform line clearances
- Provide raw material releases
qualifications: QUALIFICATIONS :
- Education: B.S. in Chemistry or related field with 2 -5 years of auditing and SOP writing experience.
- Knowledge/Skills: Working knowledge of computers, including Microsoft Word, Outlook, and Excel. Basic knowledge of manufacturing facilities and equipment such as fluid bed dryers, granulators, coaters, mixers, etc. is helpful. Basic knowledge of operation of analytical instruments such as HPLC, GC, TOC, UV, FTIR, Dissolution, Karl Fisher moisture determination, pH, conductivity, and general equipment to perform USP methods is also helpful.
- Mental Requirements: Ability to handle stress produced by time pressure, customer demands, etc.
skills: SOP, Quality Assurance, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.