In this role, you will be responsible for providing support for maintaining the instrument quality program including the creation of validation documents. The Specialist must work with Lab Operations and Quality Assurance to assure compliance with processes and procedures to reduce risk and improve compliance and productivity
location: Exton, Pennsylvania
job type: Contract
salary: $45 - 50 per hour
work hours: 9 to 5
- Create electronic instrument equipment validation plans in the tracking and approval systems.
- Responsible for creation of documentation and revisions of documents to support and maintain the quality management system for laboratory instruments
- Provide input and support to maintain the project schedules and activities for new instrument installation projects.
- Review and manage instrument repair documents for compliance to work instructions
- Support all types of audits including regulatory, customer and quality management system
- Write installation qualification (IQ) documents, operational qualification (OQ) and process qualification (PQ) validation documents for new laboratory instruments purchases. Examples include chromatography, instruments, UVs and various other analytical instruments.
- Write documents such as laboratory investigations, work instructions, and procedures
- Provide updates to weekly instrument meetings on status of documents and activities
- Responsible for data input into SAP equipment, calibration and maintenance module
- Develop all key validation documents using functional, user requirements, design specifications, equipment manuals and risk assessments for fully compliant GMP instruments.
- Support and maintain the instrument quality program including annual installation qualifications, preventative maintenance documentation and instrument asset life cycle management
- Support and collaborate with lab employees, onsite contractors and outside vendors for repair and installation of lab equipment
- Must keep current with new technologies and cGMP regulations
- Support the Lab Metrology group with other activities and projects as needed
- Perform follow-up activities for metrology area of work
- Bachelor's of Science degree in a related area
- 3 years of documentation and validation experience in the pharmaceutical industry
- Strong understanding of a cGMP environment
- Experience with Quality Management Systems and good documentation practices
- Able to be aware of all relevant SOPs
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.