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CTG Document Control Specialist in Woodland, California

Document Control Specialist

Woodland, California, United States

New

Information Technology

6 days agoPost Date

21204421Requisition #

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CTG is assisting a client in Woodland, CA for a Document Control Specialist!

Pay Rate: up to $26.00/hour (based on experience)

Onsite Mon-Fri 8am-5pm

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

Required Education:

4-year Biology or Chemistry degree, or related field; or 2-year related degree with 2-4 years of experience

Required Years and Area of Experience:

0-4 years of experience in Manufacturing, Engineering and/or Quality

Required Skills:

• Ability to develop, update and train on SOPs.

• Working knowledge of ISO standards and Quality Management Systems (QMS).

• Requires Bachelor’s Degree, preferably in a scientific or technical discipline

• 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.

For immediate consideration please email rebecca.olan@ctg.com

CTG is a leading provider of digital transformation solutions and services that accelerate clients' project momentum and achievement of their desired IT and business outcomes. Our vision is to be an indispensable partner to our clients and the preferred career destination for digital and technology experts. CTG has operations in North America, South America, Western Europe, and India. For more information, visit www.ctg.com.

Our culture is a direct result of the people who work at CTG, the values we hold, and the actions we take. In other words, our people are the culture. It's a living, breathing thing that is renewed every day through the ways we engage with each other, our clients, and our communities. Part of our mission is to cultivate a workplace that attracts and develops the best people, reflected by our recognition as a Great Place to Work-certified company across many of our global operations.

CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws.

CTG is an Equal Opportunity and Affirmative Action Employer. CTG will assure equal opportunity and consideration to all applicants and employees in recruitment, selection, placement, training, benefits, compensation, promotion, transfer, and release of individuals without regard to race, creed, religion, color, national origin, sex, sexual orientation, gender identity and gender expression, age, disability, marital or veteran status, citizenship status, or any other discriminatory factors as required by law. Our Affirmative Action program serves to promote occupational equality and diversity through good faith efforts. CTG is fully committed to promoting employment opportunities for members of protected classes.

Additional Information

  • Job Function: Customer Support

  • Education Level: Associate's Degree/College Diploma (±13 years)

  • Work Remote: No

  • Travel: No

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