Manufacturing Document Specialist II

In this role as a Manufacturing Documentation Specialist II you will:

* Collaborates with the Quality department to manage and track Change Requests.

* Creates or revises new materials and new material specifications.

* Creates or Revises production procedure/QC procedures.

* Reviews documents for format, accuracy and compliance with existing procedures, providing feedback on content as appropriate in collaboration with area experts.

* Creates and revises label specifications in Label Content Records (LCRs), templates and processes manufacturing updates through DIR workflow.

* Participates in CR Meetings and NPIs as required to support creating and revising documents and ERP data.

* Maintains the Document Storage Area for all controlled documents.

* Conduct manual create Recipe and BOM setup on SAP.

* Troubleshoot for label printing issues as needed.

* Create department SOPs, Work Instruction, Packaging/dispensing procedures if needed.

* Trains new Documentation Specialists.

* Perform required Product Lifecycle Management (PLM) System changes through document routing approval, Tier 2, and Engineering Records (ER) release as needed.

* Filling/archiving product batch records.

* Evaluate change requests/logging the requests.

* Update/create KMI.

How You'll Make An Impact:

* Contribute to production/QC/dispensing/packaging to have correct SOP to follow and make consistent and high quality product.

* Contribute to ensure the material specification correct and give the buyer right material specification to purchase the right material.

* Contribute material recipes/BOM setup/revision to ensure the product std cost is correct. That can reflect the cost of the product.

* Contribute to create label and label content to ensure the product has right information on the label. Troubleshooting label print issues to ensure the product is released on time.

* Contribute to launch the change request and to ensure the change request to be approved and released in timely matter.

What You Bring:

* Education:

Bachelor's degree or equivalent (science field preferred).

* Work Experience:

3-5 years in a regulated industry (medical device, pharmaceutical, biotechnology preferred).

* General knowledge of Good Documentation Practices (GDP)

* Formal Training and/or Certification in CAD/Solidworks preferred.

* Skilled in desktop publishing tools such as Auto Cad, and Solidworks preferred.

* Strong oral and written communication skills.

* Proficient with ERP systems such as SAP.

* Proficient in Microsoft Word, Excel and Visio.

* Knowledge of medical device regulations (QSR, ISO 13485, etc.) and medical device manufacturing operations.

* Ability to share knowledge and train employees as needed.

* Ability to understand processes and systems and put them into written word

* Good problem solving, organization, multitasking skills required.

Location:

This position must be based in Hercules, California and requires the employee to be located within commuting distance of the office.

Total Rewards Package:
At Bio-Rad, we're empowered by our purpose and recognize that our employees are as well. That's why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee's work and life cycle.

Benefits:
We're proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG's), and more!

Compensation:
The estimated base salary range for this position is $70,310 to $95,400 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. This position is eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance.

Who We Are:

For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Bio-Rad offers a unique employee experience with collaborative teams that span the globe.

Here, you are…