 Operation Specialist
 Operation Specialist
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Salary Not Disclosed
1 Vacancy
Job Description
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.
Hours of work/work schedule/flex-time: 40 hours/week Monday-Friday
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.
- 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
- Minimum required: Associate degree and relevant experience
- Preferred: Bachelors degree in biology or chemistry
- 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).
- 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.
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.
Employment Type
Full-time
