Biochemist 1

Duration: 12+ Months

Job Category: Operations

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1B’s
Work hours: 8 am to 5 pm or 9 to 6
Remote or onsite: hybrid, depending on the work to be accomplished, must be local

 

Roles & Responsibilities

3 Must haves on the resume: Manufacturing, Documentation, Engineering Change Order (ECO). SAP is a plus.
Work with various functions such as Supply and Production Planning, Procurement, MDO, Manufacturing to coordinate and execute IVDR associated activities in San Jose Reagent Manufacturing to meet the BDB IVDR program timeline and deliverables.

• Create and update manufacturing documents (Specifications and procedures) and master data (BOMs and routings) impacted by the IVDR programs. Prepare and submit ECRs and ECOs. Work with other functions to collect information, monitor, analyze and update status until completion.
• Work in Documentum, SAP and other document archives to gather and review available documentation. Retrieve, compile, summarize manufacturing and QC test data in reports; create or update flow charts and documents to support regulatory submissions.
• Coordinate with Planning and Manufacturing to ensure manufacturing readiness of phase out of old versions and phase in of new versions of products in the implementation of labelling and packaging changes until product launch.
• Provide data and information to support data load and ongoing data maintenance.
• Perform other tasks as assigned to support IVDR and Reagent Operations.

Experience Required

• Prior experience in a FDA or ISO medical device regulated manufacturing environment and knowledge of medical device documentation, product labeling, manufacturing and business process are desirable.
• The preferred candidate will demonstrate excellent organizational skills, and the ability to manage multiple/changing priorities and effectively work in a team environment

Skills & Certifications

• General knowledge of Microsoft Word and Microsoft Excel, and the ability to learn and function competently within SAP software environment.
• Requires good documentation (maintaining clear and concise records) and effective communication

Eligibilities & qualifications

• Requires a Bachelor’s degree in biological sciences and 1 year of experience in a manufacturing or laboratory environment or related business/industrial experience.
• Knowledge of general laboratory safety, GMP\'s and associated regulatory requirements