10450 Science Center Drive, B1 San Diego, CA 92121 US
This person is to assist and support the organization with GMP compliance; monitoring of conformance to established quality assurance processes and GMP standards for manufacturing. Performs initial evaluation of required documentation. Assists in the identification of risk and deficiencies while working with internal departments/business units to appropriately remedy them. Facilitates internal training on quality assurance requirements, processes, and procedures. This person will represent QA during production activities.
1. Provide exceptional customer service to our internal and external customers in all assigned tasks.
2. Maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMP)
3. Provide floor support for GMP activities
4. Monitor for GMP compliance of all in-process activities during GMP processing.
5. Perform AQL particle inspection of in-process product vials prior to packaging. This process requires a complete eye exam and the successful completion of a visual inspection test within the first 3 months of employment.
6. Gown qualified for entry into controlled manufacturing areas to perform quality functions as assigned.
7. Perform real time review of executed Batch Documentation and prepare for eventual disposition by QA management.
8. Organize documentation for Batch History Files and scan files.
9. Ability to search, document and generate quality event reports for Batch Release.
10. Assist with regulatory inspections and partner audits with management oversight.
11. Maintain databases as required
12. Other duties as assigned
This person has no direct supervisor responsibilities.
Interaction: Continuously interacts with other members of the Manufacturing, Quality Control, Supply Operations, Microbiology, Product teams.
Education and Experience:
• Minimum 1 year of relevant Pharmaceutical Industry Quality Assurance experience preferred.
• BS/BA degree in scientific discipline from an accredited college or university or equivalent preferred or equivalent work experience.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job requires weekend, holiday and off shift work hours.
Knowledge, Skills, and Abilities:
1. Strong knowledge of GMP’s and their application
2. Prior experience with Batch Documentation review
3. Ability to work proactively and cooperatively with managers and operational staff to solve quality problems
4. Ability to manage multiple responsibilities with a high degree of self motivation
5. Good written, oral and interpersonal English communication skills
6. Ability to use Microsoft Word and Excel applications
7. Ability to accommodate production requirements that include working extended day hours and weekends
Typical office setting, cubicles, noise level is moderate with consistent printer, telephone ringing and conversation.
The work environment also includes warehouse and manufacturing areas.
This position requires the individual needs to be able to aseptically gown.
Pay Rate Range: $20-28/hr. Salary will be commensurate with experience
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.