BD (Becton, Dickinson and Company) QA Document Specialist II in San Diego, California
Job Description SummaryResponsible for supporting the execution of the Document Control and Engineering Change systems activities in accordance with ISO9001 and company quality standards. including expeditious processing of changes to SOP's and other content, tracking and initiating change orders associated with documentation and SAP objects, and securing completed documentation. This position is further responsible for updating Quality SOPs and work instructions and removing obsolete documentation from circulation.
The QA Document Control Specialist II will also be responsible for supporting external customers as well as the following internal customers including Operations personnel and management, Production Planning, Quality Engineering, R&D, CTT and Logistic personnel.
Provide SAP training to Document Control Specialist I’s for document control related responsibilities in SAP. Support the creation of SOPs, manufacturing specifications and other required documentation by exporting from source system, formatting and word processing. Initiate, coordinate, and manage the Engineering Change Request and Orders (ECR/Os) process using SAP tools. Assist in the review of documents and data (internal and customer facing) for completeness and accuracy. Creation of certificates and other documents for external customers Assist in writing and reviewing department procedures and SOPs. Promotes a safe work environment. May provide recommendations on maintaining the safety of the work environment. Participates in Environmental Health and Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisor of all observed hazardous conditions or unsafe work practices. Provide recommendations to support systems that continuously improve product/process quality and product availability, reduce cost, and increase production capability. 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 his/her working area. Brings regulatory compliance questions/issues to the attention of management. Assist in the evaluation of resumes and participate in hiring decisions for QA Document Control Specialist Interact with all disciplines at BDB San Diego, other BDB plants and BD affiliates. Work on special projects for QA/RC Management as needed. Perform other related duties and assignments as requested by management. Local travel to other BD Biosciences - San Diego facilities may be required.
KNOWLEDGE AND SKILLS
Able to follow verbal and written instructions.
Able to deal with ambiguity.
Able to work independently with minimal supervision.
Able to perform multiple activities in a fast-paced environment.
Strong organizational skills.
Good communication skills, both verbal and written.
Good interpersonal skills with the ability to handle conflict.
Strong personal computer skills required, including the use Microsoft Word, Microsoft Excel, and the use of email. Ability to perform a wide range of tasks relating to data manipulation and transformation in Excel.
This person can work independently and in a team environment.
Other desired skills include:
SAP & FileMaker database knowledge
Understanding of master data in a manufacturing and/or Bio environment
Knowledge of chemicals
Knowledge of Safety Data Sheets and/or Registration, Evaluation and Authorization of Chemicals (REACh) requirements for Europe.
Primary Work LocationUSA CA - San Diego (BDB)
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status