Quality Control Analyst - Environmental Monitoring

Job Title:

Quality Control Analyst II

Department:

Quality Control

Reports to:

Supervisor, Quality Control

Overview:

This position will report to the Quality Control Supervisor. This position will provide coordination of the Environmental Monitoring Program and all supporting functions to ensure successful monitoring of ISO classified cleanrooms and GMP operations. Other supporting duties include, but are not limited to assisting management or other departments in investigations, writing technical documents, and preparing trend reports.

Essential Duties & Responsibilities:

• Collecting environmental and personnel monitoring samples
• Processing environmental and personnel monitoring samples
• Recording, reviewing and trending environmental monitoring data
• Preparing trending reports
• Presenting trending reports
• Scheduling environmental monitoring events
• Assisting with environmental excursion investigations
• Training new employees as needed
• Writing technical documents in a clear and concise manner
• Maintaining department training records
• Maintaining adequate inventory of test supplies
• Performing weekly laboratory equipment maintenance
• Performing all work according to company policies, SOPs and cGMP practices
• Following verbal and written instruction
• Interacting with other departments and outside vendors in a professional manner
• Working in a safe manner, which is compliant with OSHA and company safety policies

Managerial Responsibilities:

· This person has no managerial responsibilities.

Education and Experience:

• BS or BA in a scientific field, preferably microbiology or biology
• 3-4 years of applicable experience is required
• cGMP experience is required
• Environmental Monitoring experience is expected
• Aseptic technique or tissue culturing experience is a plus
• Proficient with Microsoft Word and Excel software

Working Environment:

• Must be able to work aseptically in controlled environments requiring special gowning (ie. cover the head, face, hands, feet and body).
• No make-up, nail polish or artificial fingernails may be worn in the work environment.
• Must be able to work in a moderately noisy environment.
• Must be able to work around bio-hazardous materials and chemicals such as alcohol, acids, and/or buffers.

Physical Demands:

· Must be able to lift, push, and/or carry up to 25 lbs.

· Must be able to use hands, fingers to handle and feel objects, tools, and controls.

· Must be able to sit or stand for long periods of time. Regularly required to sit, walk, climb, stoop, kneel, crouch; use handle or feel; and reach with arms.

· Must be able to successfully pass routine gowning and aseptic qualifications.

· Must be able to work in aseptic areas and in compliance with 21 C.F.R. 211.28(b), a copy of which is attached.

Note: This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job which may include other duties as assumed or assigned.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

COVID-19 considerations:
Social distancing and remote work when available

Education:

• Bachelor's (Required)

Experience:

• Laboratory Experience: 3 years (Preferred)

Work Location:

• One location

Work Remotely:

• No