Operation Specialist

DivIHN (pronounced "divine") is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

Visit us at to learn more and view our open positions.

Please apply or call one of us to learn more

DivIHN (pronounced "divine") is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

Visit us at to learn more and view our open positions.

Please apply or call one of us to learn more

DivIHN (pronounced "divine") is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

Visit us at to learn more and view our open positions.

Please apply or call one of us to learn more

For further inquiries regarding the following opportunity, please contact our Talent Specialist

Ragavendar at 224.394.4900

Title: Operation Specialist

Location: Woodland, CA

Duration: 6 Months with possibility of extension based on demand.
Hours of work/work schedule/flex-time: 40 hours/week, Monday-Friday

Preferred Time zone: EST



Scope of Position:

• 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
• 3 years of experience in Manufacturing, Quality, and/or Document Controls
• Hands-on experience or exposure to working in controlled environments such as pharmaceutical, biotechnology, or medical industries, ensuring adherence to regulatory standards.
• Handles documentation flow for change controls, ensuring all required approvals and routing steps are completed efficiently
• Responsible for maintaining accurate and up-to-date training records across all departments.

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.
• ISO standards and Quality Management Systems (QMS).
• Standard Operating Procedures (SOPs).
• Microsoft Word, Excel, and PowerPoint.

Preferred Skills:

• Cell culture or microbiology lab experience
• SAP or PeopleSoft ERP system experience

Interview Process: 1:1, One Round Onsite Interview, Interview Format: Onsite

About us:

DivIHN , the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.

About us:

DivIHN , the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.

About us:

DivIHN , the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.

About us:

DivIHN , the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.