QC - Environmental Monitoring Technician (Day Shift)

About the role

The QC Environmental Monitoring Technician will provide support for Parenteral Operations by performing environmental monitoring of the classified manufacturing areas and by performing utility sampling and analysis within the Parenteral Operations and QC Laboratory buildings. The QC Environmental Monitoring Technician will assist the QC Environmental Monitoring management with training QC Environmental Monitoring Technicians and providing support in the manufacturing areas during routine environmental monitoring and utility sampling.

Responsibilities

• Adhere to and promote compliance with all cGMP procedures, Quality Systems, and Good Documentation Practices.
• Provide support for Parenteral Operations activities by performing environmental monitoring of classified manufacturing areas.
• Provide support for manufacturing and laboratory activities by performing utility sampling and analysis within the Parenteral Operations and QC Laboratory buildings.
• Assist with technical training and mentoring of QC Environmental Monitoring Technicians through formal process/program.
• Participate in department/company continuous improvement projects and initiatives.
• Assist with authoring Standard Operating Procedures and Work Instruction documentation.
• Adhere to and promote compliance of all safety standards.

Requirements

Education

• High School Diploma or equivalent; Associate Degree preferred.

Experience

• 3+ years of demonstrated relevant experience performing Environmental Monitoring in a GMP Pharmaceutical Manufacturing facility, preferably associated with aseptic production.
• Demonstrated ability in performing environmental monitoring techniques including, but not limited to: viable surface monitoring, viable and non-viable air monitoring, compressed air monitoring, and water (potable, purified water, water for injection, clean steam) collection and analysis.
• Previous experience with Laboratory IT systems such as LIMS, LES, and MODA.

Qualifications

• Experience with cGMP requirements and regulatory compliance associated with a cGMP Manufacturing facility.
• Strong interpersonal skills and ability to train/mentor QC Environmental Monitoring Technicians.
• Strong oral and written communication skills for communicating to colleagues, management, and other departments.
• Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.
• Ability to gown into facility dedicated cleanroom attire, as required to perform job responsibilities.

Other information

• The role will be phased from a project support role to a routine support role as the development facility and processes progress.
• Tasks may require repetitive motion and standing or walking for long periods of time.
• Tasks may require lifting of up to 30 pounds and may require the ability to pass, push, and pull to execute specific aspects of the job role.
• Ability to work 12-hour shifts.
• Ability to have a flexible schedule as the position may require training or working on day/night shift for a short duration prior to transitioning to designated day/night shift.
• Travel will be required during the project phase for training and implementation of the Environmental Monitoring Program for the Concord site.

Pay

The anticipated wage for this position is $18.75 - $35.96 per hour. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). Actual compensation will depend on a candidate's education, experience, skills, and geographic location.

Benefits

• Company-sponsored 401(k)
• Pension
• Vacation benefits
• Medical, dental, vision and prescription drug benefits
• Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• Life insurance and death benefits
• Certain time off and leave of absence benefits
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)