Quality Systems Coordinator
The Quality Systems Coordinator supports the daily execution of Quality System processes such as, but not limited to, Document and Record Control, Change Control, Personnel Training, Deviations, Nonconformance, CAPA, Management Review, Audit, etc.
Job description (including by not limited to the following):
- Creates/revises Standard Operating Procedures (SOP) and work instructions.
- Initiates, routes, and implements Change Requests as assigned.
- Distributes new and updated SOPs, Forms, WIDs
- Collects superseded and obsoleted SOPs, Forms, WID’s.
- Coordinates periodic review of SOPs.
- Files GMP records including, but not limited, batch records, purchase orders, complaint records, training records, etc.
- Coordinates archival, retrieval, and destruction of GMP records from off-site storage facility
- Supports backroom (war room) activities on regulatory and 3rd party inspections
- Coordinates completion and approval of Deviations and CAPAs.
- Coordinates recall activities as assigned.
- Trains and provides guidance on Quality System processes and related activities
- Collects and compiles data from various Quality System databases and presents to Operations Management team.
- Participates in team meetings and strategizing sessions
- Participates in continuous improvement initiatives
- Behaves ethically in all situations, and reports or challenges unethical behavior of others
- Performs other tasks as assigned.
Skills and Requirements:
- Minimum of 1 year experience in pharmaceutical operations required.
- High School Diploma or equivalent required. Bachelor’s degree preferred, health sciences preferred. Internal auditing experience is a plus.
- Working knowledge of FDA GMP regulations and quality system regulations/requirements
- Knowledge of manufacturing processes.
- Good communication skills at all levels, both written and verbal; both individually and in a group setting.
- Strong skills in analytical thinking and problem solving.
- Ability to perform multiple tasks and ability to effectively manage conflict.
- Ability to work in teams to obtain results.
- Proactively identify issues and take action. Good decision making skills. Ability to make decisions with limited information. Effectively manage change and comfortable changing direction and acting without complete information.
- Good organizational and prioritization skills.
- Must have working knowledge of basic PC software: Excel, MS Word, PowerPoint, etc.
Temporary position located in the Conejo Valley area. Pay is $17.50 hourly. Candidate will be required to pass drug screening and background check.
Royal Staffing Services will consider for employment qualified Applicants with Criminal Histories in a manner consistent with the requirements of the Los Angeles Fair Chance Initiative for Hiring.