Job Description

Quality Systems Spc I Doc & Data Mgt - San Diego, CA 6 Month Contract M-F 8-4:30 #39174

3 ideals on the resume: ** QA/Document Management/Change Management work experience, especially in life sciences; ** Bachelor’s degree or other work experience in life science; ** SAP experience

Interviews type: ** Phone interviews with hiring manager and team

Has developed knowledge and skills in Quality Assurance/Document Management/Change Management. 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. The QA Specialist 2 will also be responsible for supporting external customers as well as internal customers.

DUTIES AND RESPONSIBILITIES Document and Change Management 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.

Other Activities: ** Ability to handle several work streams simultaneously, multitask, and set priorities effectively to complete daily demands. ** May lead or participate in special projects directed to the continual improvement of the department or other cross-functional projects. ** Consult with colleagues to seek information about unique problems and to identify problem solving options and strategies. ** Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements. ** Participates as required in training on regulatory issues affecting own area of work. ** Bring regulatory compliance questions/issues to the attention of department management. ** Promotes a safe work environment. ** May provide recommendations on maintaining the safety of the work environment. ** Participates in EH&S programs. ** Addresses corrective actions whenever a hazard is identified. ** Notifies supervisor of all observed hazardous conditions or unsafe work practices. ** Performs other related duties and assignments as required

MINIMUM QUALIFICATIONS 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.

EDUCATION AND EXPERIENCE ** High School Diploma or equivalent. AS degree or college level courses helpful. 2 years relevant experience or a combination of equivalent education and relevant experience. ** Self-driven and detail oriented. ** Effective written and oral communication skills. ** Effective time management skills. ** Effective interpersonal skills.

Company Description

www.techdataservice.com