CTG BATCH RECORD REVIEWER in Frederick, Maryland
BATCH RECORD REVIEWER
Frederick, Maryland, United States
Jul 15, 2020Post Date
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Batch Record Reviewer
Pay Rate: $22.00
Shift: MTW, 6am-7pm
The Batch Record Reviewer works as part of the QA team at our Frederick, Maryland facility. This person’s core responsibility will be reviewing Device History Records and associated documents prior to release and shipment to ensure all requirements and specifications are met.
Review Device History Records (DHR’s) and associated documents to ensure that all documents and specifications are met. Identify non-conformances and trend/report device history batch issues.
• Ensures activities and items are in compliance with both company quality assurance standards and applicable quality system regulations. Resolve incomplete or unexplained issues found during the batch review with manufacturing.
• Review finished good batch records and perform finished good inspections as required
• Verify finished good labels for accuracy
*Minimum Qualifications (must have)
• Bachelor's Degree in Scientific/Technical field (i.e. Chemistry, Biology, or Engineering) or equivalent.
• Working experience in a regulated industry.
• Effective communication skills are required, both written and verbal.
*Preferred Qualifications (nice to have)
• 2 year experience in IVD, Medical Device or Pharmacuetical industry
• Working knowledge of cGMP and it's appropriate application.
MandatoryBatch Record Reviewer
DesiredContingent Hourly (CWHR)-TEM.CWHR.A00
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CTG (NASDAQ: CTG) has developed a reputation for responsiveness and reliability - traits that our clients say set us apart - since our founding in 1966. As one team, we create and deliver information and technology solutions that make our clients more successful and cultivate a workplace that attracts and develops the best people. Our vision is to be an indispensable partner to our clients and the preferred career destination for information and technology experts. CTG has operations in North America, South America, Western Europe, and India and regularly posts news and other important information online at 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.
Job Function: Customer Support
Education Level: Bachelor's Degree (±16 years)
Work Remote: No