Job Description

POSITION: QUALITY DOCUMENT SYSTEMS MANAGEMENT LOCATION: SAN DIEGO, C 92121 CONTRACT TERM: 6+ MONTHS PAY RATE: $30-40/HR SCHEDULE: 8:00AM-4:30PM (FLEXIBILITY) SCREENINGS: BACKGROUND AND DRUG SCREENINGS PRIOR TO START DATE BENEFITS: ACA COMPLIANT BENEFITS AVAILABLE QUALIFICATIONS: 

• QA/Document Management/Change Management work experience, especially in life sciences
• Bachelor’s degree or other work experience in life science
• SAP experienceHas developed knowledge and skills in Quality Assurance/Document Management/Change Management.

RESPONSIBILITIES: 

• Applies knowledge and skills to a variety of standard activities. Works with moderate guidance in own area of knowledge.
• As directed by the Quality Assurance leadership, the Quality Assurance Specialist II is accountable for support of the continued development, improvement and implementation of the site Quality Systems.
• This position actively participates in quality guidance and product resolution decisions to New Product Development, Operations, and project teams for process improvement and continuous improvement activities.
• Prepare, create and maintain various types of documents such as drawings, quality documents and manufacturing specifications for Client products and services. Work with cross-functional associates who are submitting and reviewing information for the preparation of various documents to ensure accuracy and appropriate format per company standards. Helps in trouble-shooting document formatting word processing problems and supplies assistance to associates within department and other cross-functional groups, as necessary.
• Perform ECO Analysis and assist in preparation of ECR’s. This includes the assembly of necessary documentation and SAP objects of record (i.e. materials and documents).
• Proactively researches, reviews, and/or checks ECOs for discrepancies against information provided in ECOs (i.e. redlines), consults with department supervisor and Change Order Requesters to resolve discrepancies and issues. Participates in product team activities to assist product release using the ECO Process. Performs data entry functions as required by business processes and responsibilities.
• Provide analysis support, prepare, and maintain ECOs working with internal project teams throughout the life cycle of Client products. Assess impact of ECOs, and manage their execution. Provide timely updates to management, project teams and other associates.
• Ensures all ECO changes occur in a timely manner and performs the necessary follow-up to prevent any conflicts or delays to business goals. Proactively manages department and/or personal metrics to ensure goals are tracked and met.

KNOWLEDGE AND SKILLS: • Detailed-Oriented, can deal with ambiguity, team player & must be able to work independently and with minimal supervision. Fast learner and must have excellent communication skills. • Daily working knowledge of SAP. Proficient in MS Office (i.e. Excel, Word, Visio, and PowerPoint). Proficient in Adobe products (e.g. Acrobat Pro). • Requires organizational skills and the ability to follow verbal and written instructions. • Working knowledge of ISO 9001 and other regulatory bodies preferred. Moderate level of application of Quality system standards to assigned Quality system area. Working Knowledge of Quality Systems Regulatory requirements and application to Company/Unit requirements. Experience with Biotech/Medical Device MFG, Regulatory, or QA processes preferred.   _On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.  _

The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC.  On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.”

Company Description

On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America. ​ One of the unique aspects of On-Board is our ability to customize solutions with each of the complimentary business verticals to satisfy our partners goals including Total Solutions.