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Chemical Regulatory Compliance Scientist

Apply Now Job ID R-343848 Date posted 08/09/2019

Job Description Summary

Job Description

The position is responsible for supporting the global compliance of BDB Cell Analysis to Hazard Communication, chemical reporting and other regulations related to the chemical composition of products.  The BDB product stewardship engineer is the BDB business lead and point of contact for Reagents (Chemical Regulations).  This position will support both new and legacy product and is the SAP Global Specification database specialist.

Job Responsibilities:

  • Manage Regulatory compliance data and SAP reporting activities Liaise with the Global Product Stewardship team to ensure ongoing compliance – change management and new product development (e.g. updates to regulatory lists), changes to BDB Bills of Materials (supplier, material changes) and new product Bill of Materials, packaging (waste) reporting.

  • Operates as the SAP GSDB subject matter expert for BDB in an analyst & governance role and represents BDB in the GSDB Super User Forum for overall process, governance and metrics. Participate in Business Process Integrator meetings, representing Product Stewardship (SAP EHS) for BDB.

  • Ensure new/changed product information such as composition data is collected and entered into Halfpipe/SAP (e.g. REACH, BPR, GHS, Cal Prop 65) to support chemical reporting and compliance to product stewardship regulations.

  • Work with BDB sites world-wide in the data coordination activity including Data Migration projects/collection, data compilation and review with elimination of duplicate data Assure all plants within the BDB organization including designated plant level MDO are meeting the needed SAP GSDB requirements. 

  • Coordinate EHS Workflow/MDH (halfpipe) tasks in support of material creation for BDB business.

  • Review product ingredients/bill of material against new REACH SVHC obligations and other MOC & support ‘where used’ analysis.

  • Provide guidance, input and support to BDB R&D and Sustaining Engineering teams on product stewardship regulations and customer requirements. 

  • Review and approve customer responses and SVHC/Article statements. Review regulatory reporting data (REACH Substance Volume Tracking) including assessing requirements for new products/suppliers for San Jose and San Diego and be the REACH SVT business point of contact for all BDB sites.

  • Review data, determine uses and organize tests (when needed) to support BDB REACH Registrations dossiers, include determining Material Nature.

  • Facilitate BDB support and input for REACH Authorization dossier submissions.

  • Assess regulatory changes on a substance level and BDB product changes impact on product classification.

  • Respond to customer, BD affiliate, or regulatory agency questions regarding chemical or animal by-products in BDB Cell Analysis products.

  • Create other reports or documents as needed. 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. Interact with all disciplines within BDB and BD affiliates. Work on special projects for Management as needed. Perform other related duties and assignments as requested by management.

  • Occasional travel to other BD Biosciences facilities may be required.

Minimum Qualifications:

Education and Experience:

  • Bachelor's Degree in chemistry, chemical engineering, environmental science, biology or similar scientific disciplines required. Master's Degree preferred.

  • Minimum of 3 years' experience working in Regulatory, Product Stewardship or EH&S field, with an emphasis on hazard communication requirements.

  • Experience with key regulations in North America and Europe, including:

    • US OSHA 2012 Hazard Communication Standard

    • US OSHA 1994 Hazard Communication Standard

    • WHMIS

    • DSD/DPD

    • REACH

    • CLP

  • Knowledge of the UN GHS (Global Harmonized Standards).

  • Willingness to do business travel up to 10%.

  • Able to follow verbal and written instructions, deal with ambiguity, and work independently with minimal supervision. 

  • Able to perform multiple activities in a fast-paced environment

  • Strong organizational skills, Fast learner, and Detail oriented.

  • 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.

Other desired knowledge and skills include:

  • Background in Medical Device Reagent design and/or manufacturing.

  • Knowledge of regulations concerning materials of animal origin (e.g. EC 1069/2009, EC 142/2011)

  • Knowledge of Dangerous Goods Transportation regulations, including IATA, DOT, ADR

  • Knowledge of Cal Prop 65 impact (risk and exposure) with respect to labeling needs.

  • Familiarity with the Cartagena Protocol on Biosafety.

  • Knowledge of chemical and hazard communication regulations in eastern Europe and the Asia Pacific region.

  • Knowledge of US, state, and international chemical inventory lists.

  • Knowledge of US and international chemical waste regulations

  • Knowledge of toxicology and ecotoxicology relevant to Safety Data Sheet authoring.

  • Understanding of master data in a manufacturing and/or biotech environment.

  • SAP & Filemaker database knowledge.

  • Strong data analysis skills, including the ability to perform a wide range of tasks relating to data manipulation and transformation in Excel, Access or similar software.

#LI-TECH

Primary Work Location

USA CA - San Jose

Additional Locations

USA CA - San Diego (BDB)

Work Shift

NA (United States of America)
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