AddressRequired Visa Status:
| Citizen | GC |
| US Citizen | Student Visa |
| H1B | CPT |
| OPT | H4 Spouse of H1B |
| GC Green Card |
Employment Type:
| Full Time | Part Time |
| Permanent | Independent - 1099 |
| Contract – W2 | C2H Independent |
| C2H W2 | Contract – Corp 2 Corp |
| Contract to Hire – Corp 2 Corp |
Description:
JOB QUALIFICATIONS:
- Bachelor’s Degree in Science, Engineering or related field from an accredited college or university
- 5+ years related experience preferably in a quality assurance environment; or, an equivalent combination of education and/or experience
- Must be an effective communicator and understand written procedures
- Very knowledgeable in cGMPs, FDA regulations and guidance and other regulatory requirements in a regulated manufacturing environment
- Investigations to determine cause corrective action and prevention planning.
- Attention to detail
- Excellent interpersonal and communication skills
- Ability to follow routine verbal or written instructions
- Able to work under pressure and meet deadlines
- Computer literate
- Able to work with minimal supervision
EXPERIENCE
Required
- cGMPs, FDA regulations and guidance and other regulatory requirements in a regulated manufacturing environment
- 5 - 8 years: Experience preferably in a quality assurance environment
EDUCATION
Required
- Bachelors or better
Responsibilities:
- Analyzes data from production and laboratories, reports deviations (Manufacturing, Laboratory) and consults with other departments to identify recurrent problems, and coordinates resolution of complex quality issues.
- Researches and recommends improvements in production.
- Oversees Quality Systems related to the Product/ Technology Transfer Process.
- Complies with all Company policies and procedures, including safety rules and regulations.
- Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) and other regulatory requirements in a regulated manufacturing environment.
- Supports the training department in assessing Quality training requirements and revising them as needed. Provides training to manufacturing operators in MBR’s.
- Supports the Computer systems Validation by reviewing and approving related Qualification/Validation Protocols and Reports.
- Support site deviation system as site system administration.
- Create and review new production and packaging records.
- Review and work together with production department in the preparation and writing of deviations/investigations.
- Support the QA department compiling data, reviewing and approving APR’s for OTC products.
