CTG's long-standing Fortune 500 client of over 15 years has a W2 contract assignment for an Operations Specialist. Type: Contract Job Title: Operations Specialist Location: Woodland, CA Candidates must be able to commute and work onsite in Woodland, CA Pay Rate: $22.54/hour – $26.67/hour Work Hours: M-F 8am–5pm Education: Minimum Associate degree required; Bachelor’s in biology or chemistry preferred 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 • Drive completion and routing of change control documents and change control routings • Issue labels and batch record documentation for all products • Issue and maintain training records for all employees • Coordinate the review and revision of procedures, specifications, and forms • Assist with writing and revising MMRs and QOPs to ensure procedural accuracy and compliance with cGMP and ISO 13485 • Conduct initial review of completed batch records for Good Documentation Practices • Maintain accurate reporting and trending of on-time QC release and batch record right-first-time metrics Requirements: • 1–3 years of experience in Manufacturing, Quality, and/or Document Controls • Ability to develop, update, and train on SOPs • Working knowledge of ISO standards and Quality Management Systems (QMS) • Knowledge of computer programs such as Word, Excel, PowerPoint • Good organizational and time management skills • Strong interpersonal and communication skills Required Qualifications: Education: • Minimum: Associate degree and relevant experience • Preferred: Bachelor’s degree in biology or chemistry Qualifications: • Experience in a medical, pharmaceutical, or biotechnology environment preferred • Previous cell culture or microbiology laboratory experience preferred • SAP and/or PeopleSoft experience preferred Additional Information • No third party resumes will be accepted • Drug testing and/or other employment-related inquiries may be conducted • CTG will consider for employment-qualified applicants with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws • All interested individuals MUST be able to work on a W2 Tax basis (no C2C or third party vendors) • CTG is an Equal Employment Opportunity employer • CTG is an E-Verify Company To be considered for this opportunity, please apply directly through our website by clicking the link below or email your Word version resume and salary expectations to Jamie.Robinson@ctg.com. The expected base salary for this position ranges from $22.54/hour to $26.67/hour. Salary offers are based on a wide range of factors including relevant skills, training, experience, education, market factors, and where applicable, licensure or certifications obtained. In addition to salary, a competitive benefit package is also offered. About CTG CTG, a Cegeka company, is at the forefront of digital transformation, providing IT and business solutions that accelerate project momentum and deliver desired value. Over nearly 60 years, we have earned a reputation as a faster and more reliable, results-driven partner. Our vision is to be an indispensable partner to our clients and the preferred career destination for digital and technology experts. CTG leverages the expertise of over 9,000 team members in 19 countries to provide innovative solutions. Together, we operate across the Americas, Europe, and India, working in close cooperation with over 3,000 clients in many of today's highest-growth industries. 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 define our 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 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. CTG is fully committed to promoting employment opportunities for members of protected classes.