Pay rate: $30.00 - $40.00 per hour based on experience.
Day or Night shift available
6AM – 6PM or 6PM – 6AM
24/7 operations schedule 1st week 2 days on 2 days off next week 3 days on 3 days off Rotating schedule
As the Manufacturing Process Specialist, you are a technical expert supporting and overseeing the manufacture of biological products. You will provide technical expertise to ensure that production activities and the sampling and testing of materials and products are completed in compliance with all applicable procedures and regulations. You will monitor key process parameters. You will support troubleshooting efforts, document manufacturing problems as required, provide technical support and will identify and support implementation of process improvements.
- Provide primary (on floor) production oversight to ensure execution according to standard operating procedures.
- Observe processing activities; identify and document processing issues.
- Recommend corrective/preventative measures aimed at improving compliance and reducing repeat occurrences.
- Identify process improvements related to safety, environmental, quality, compliance, productivity, yield, and cost.
- Review and monitor process trends and process data on trained procedures.
- Review documentation in SOP's, logbooks and other GMP documents.
- Demonstrate expertise in a number of the following areas: cGMPs, FDA regulations, Cell culture, chromatographic purification, ultrafiltration, diafiltration, viral inactivation, filter integrity testing, or pharmaceutical water systems and utilities.
- Provide documentation support for SOP/ Batch Record revisions, identify and communicate necessary document changes to ensure timely revision to all SOP and batch records and review and approve SOP and Batch record revisions.
- Associate's degree / Bachelor's preferred, focused degree in Technical area is highly desirable
- At least 2-5+ years of related experience in a cGMP manufacturing environment, biopharmaceutical, or pharmaceutical industry
- Ability to interpret and carry out a variety of technical or other instructions
- Ability to apply principles of logic or scientific thinking to define and deal with intellectual and practical problems, involving abstract and concrete variables in standardized situations, and collect data, establish facts, and draw valid conclusions
- Ability to make innovation part of the site agenda and be an active driver of innovation, thinking outside of the box and challenging others to do the same
- Providing training and/or mentoring to others
- Ensuring compliance including adherence to local, state, and federal regulations and guidelines (EPA, OSHA, cGMP, FDA).
- Expertise in one or more of the following areas highly desirable: Cell culture, chromatographic purification, ultrafiltration, diafiltration, filter integrity testing, or pharmaceutical water systems and utilities
The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG®) is one focus within the full array of Kelly Services® workforce solutions.
Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.
The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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