Manufacturing Document Specialist II

About the role

In this role as a Manufacturing Documentation Specialist II, you will collaborate with the Quality department to manage and track Change Requests. You will create or revise new materials and material specifications, production procedures, QC procedures, label specifications, and packaging/dispensing procedures. You will also troubleshoot label printing issues and train new Documentation Specialists.

Responsibilities

• 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.
• Create department SOPs, Work Instructions, Packaging/dispensing procedures if needed.
• Trains new Documentation Specialists.
• Fills and archives product batch records.
• Evaluates change requests and logs the requests.
• Updates/create KMI.

Qualifications

• Education: Bachelor’s degree or equivalent (science field preferred).
• Experience: 3-5 years in a regulated industry (medical device, pharmaceutical, biotechnology preferred).
• Knowledge: Formal training and/or certification in CAD/Solidworks preferred. Skilled in desktop publishing tools such as AutoCad, and Solidworks preferred.
• Skills: 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.
• Other: 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, and multitasking skills required.

Benefits

Total Rewards Package includes competitive and comprehensive benefits such as medical plans, HSA funds, life and disability insurance, parental leave, 401k plus profit sharing, an employee stock purchase program, mental health platform, 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!

Pay

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.

Schedule

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