Quality Specialist - II
Our client, one of the most important companies in the Pharmaceutical Industry, is seeking an Quality Specialist with experience in quality control and environmental monitoring.
Job Title: Quality Specialist - II
Duration: 6 Month Contract
Location: Onsite role at West Point, PA - 770 Sumneytown Pike, West Point, PA 19486
Hours: M- F 8am - 5pm - flexible shift start time (anywhere from 7am-9am EST).
Typical Day:

• Periodic check ins with day-to-day manager
• Check in on the progress of assignments.
• Checking for daily testing reports and evaluating the data.
• Monitoring EM metrics
• Reviewing daily data and compiling data in to the report
• Compiling testing reports
• Data management and review
• Create and/or maintain EM schedules, sampling locations, and area sampling maps

• Bachelor’s degree in Microbiology, Biological Sciences or Chemical Sciences/Engineering with minimum of 5 years relevant experience, or a Master’s degree with 3 years of relevant experience

• Previous experience in an EM (environmental monitoring) role supporting sterile, biologic, or vaccine operations, and/or process development activities.
• Previous experience in aseptic unit operations.
• Previous experience in a regulated environment or knowledge of cGMPs.
• A good understanding of the regulatory guidelines governing GMP and sterile manufacturing is important.

• GLIMS
• MEDS system for Document repository
• Experience with MS office suite.

• Candidate is expected to work in a team atmosphere in collaboration with Supervisors, Process Engineers, and Equipment Maintenance Engineers.
• The selected person will support projects/programs and collaboratively resolve problems and issues through excellent communication, proactive planning, and project management skills.

• Execute classified facility, utility, and aseptic processing area EM Program requirements.
• Manage change that supports improvement to the EM program and area sterility assurance.
• Support investigation of EM events.
• Trend and evaluate data (e.g. Classified facility Qualification, Requalification, Performance Qualification, Microbial Isolates review, Investigation trending, Process Simulation support, etc.)
• Manage/maintain department EM metrics. Provide detailed analysis of metrics to SLP management for development of action plans.
• Use LIMS to plan EM sampling tasks. Create and/or maintain EM schedules, sampling locations, and area sampling maps.
• Create, update, review, and/or approval Standard Operating Procedures.
• Conduct routine EM tasks, including but not limited to troubleshooting tester questions, making decision on EM data review, planning facility requalification sampling, and ensuring routine reports are completed on schedule.
• Support Utilities EM requirements, including clean gas and water sampling data trending.
• Review facility HEPA filtered air velocity documentation.
• Actively working in a multi-discipline cross functional project team environment

If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of:Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.