QA Documentation Specialist

Job Description

Job Description

Title: Operation Specialist

Location: Woodland, CA 95776

Duration: 6 Months with possibility of extension based on demand.

Work schedule: 40 hours/week, Monday-Friday

Pay: 27.58/Hr on W2

• Ensure customer requirements are consistently met by maintaining Serum CoE quality systems and platforms.
• Effectively take action when non-conformances are found.
• Ensure that documented practices meet the true interpretation of the Serum CoE Quality Management System.

Day to Day Responsibilities:

• Support Serum CoE Quality Systems by creating, maintaining, and executing Quality Systems in compliance with ISO 13485 and FDA 21 CFR 820.
• Compile and organize all quality related documentation and ensure all documents are filed in a manner that allows for easy access for regulatory and customer audits.
• Drives completion and routing of change control documents and change control routings.
• Issuing of labels and batch record documentation for all products.
• Issues and maintains training records for all employees
• Coordinates the review and revision of procedures, specifications and forms.
• May assist with writing of new and revising existing MMRs and QOPs to ensure procedures are accurate, up to date, and are in compliance with current Good Manufacturing Practices and ISO 13485.
• Responsible for initial review of completed batch records for Good Documentation Practices
• Maintains accurate reporting and trending of on-time QC release and batch record right the first-time metrics

Education:

• Minimum required: Associate degree and relevant experience
• Preferred: Bachelor's degree in biology or chemistry

Required Years and Area of Experience:

• 1-3 years of experience in Manufacturing, Quality, and/or Document Controls

Required Skills:

• Ability to develop, update and train on SOPs.
• Working knowledge of ISO standards and Quality Management Systems (QMS).
• Experience in a medical, pharmaceutical or biotechnology environment preferred
• Previous cell culture or microbiology laboratory experience preferred
• SAP and/or PeopleSoft experience preferred.
• Knowledge of computer programs, such as Word, Excel, Powerpoint, etc.
• Good organizational skills; strong time management skills.
• Strong interpersonal and communication skills.

Interview Process: One Round Onsite Interview