job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A longtime partner who prides itself on being a leader in many different practical manufacturing processes to better serve the entire population is renowned for pioneering new treatments for renal diseases, immune disorders, and more; the focus is on patient care. If you're looking to be a part of an impactful team, you won't be disappointed!
location: Irvine, California
job type: Contract
salary: $30.00 - 35.82 per hour
work hours: 9 to 5
- Responsible for document distribution, document archiving, document/records retrieving and training process. Perform data and document management processing in the Company document system of record.
- Write, review, analyze and revise SOPs and submit procedural changes as needed to meet Corporate, Plant and Regulatory requirements.
- Participates in external/internal assessments and audits. Supports process with timely closure of observations/audits items.
- Conducts reviews of documentation and reports for conformance to procedures, protocols and regulatory requirements.
- Acts as the training Learning Professional for the site, coaches and provides training to new and existing users on TcU and BaxU,
- Assist in training internal and external personnel on documentation related processes systems.
- Provides coaching and support to leaders in the creation and management of employee training plans.
- Maintains and manages training course completion records in BaxU.
- Responsible for the training monitoring/audit process for manufacturing and quality inspectors.
- Responsible for the document management entry in TcU processing in the TcU (System of Record).
- Administers and maintains relevant databases, preparing and issuing reports as defined by the area as well as developing custom reports or controlled forms as needed.
- Serves as the Subject Matter Expert (SME) by maintaining a high level of expertise in current regulatory requirements.
- Responsible for revising and reviewing pertinent documents, records and reports against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on regulatory requirements and internal guidelines.
- Document configuration and product data (BOMs, specs) management.
- Reviews documentation for accuracy and compliance to procedures. Release or reject as appropriate. Ensure all document and system elements are identified, accurate and assembled for review and approval.
- Owns the site's On the Job Training (OJT) program. Performs training, assists in the development of the job analysis and training course content.
- Maintains and owns internal documents
- Assists in external and internal audits by maintaining audit records, extracting data from databases and creating reports, collecting relevant data, etc.
- Maintains, updates and archives site documents and records in accordance with company procedures.
- Creates and or analyzes metrics and reports to identify improvements opportunities.
- Supports Quality Assurance activities including change control, CAPA, quality metrics monitoring, internal auditing, and database management.
- Supports the timely release of in-process and finished products.
- Supports the internal and external document review process.
- Other duties as assigned.
- BS in business/science or equivalent degree.
- 3-5 years experience in Quality with a medical device / Pharma company or other similarly regulated industry. Prefer document control or quality system related experience.
- Physical Demands & Working Environment
- (The physical demands & working environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
- Exceptional organizational skills and ability to plan and implement resolutions to problems. Familiarity with auditing techniques, interpreting regulations and quality systems.
- Working knowledge of electronic documentation and/or data management systems.
- Working knowledge of ISO 13485 and/or ISO 9000, FDA regulations, application of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
- Strong interpersonal skills, self-motivated and great attention to detail are necessary.
- Must be a strong team player with good problems solving, and good verbal and written communication skills.
- Project management skills (organization skills/ follow-up / communication/ status updates)
- Proficient in Microsoft Office software systems (Word, Excel, PowerPoint)
skills: Quality control, SOP, MS-WORD, MS-EXCEL, MS-Powerpoint, 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.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.