Quality Control Environmental Monitoring Associate (Columbia, MD)

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

Quality Control Environmental Monitoring Associate conducts environmental monitoring (EM) according to Standard Operating Procedures (SOPs) in a cleanroom facility. Receives and ships in-process and final product samples. Performs preventative maintenance of laboratory equipment and monthly cleanings. Processes and evaluates environmental monitoring samples according to SOPs. Applies knowledge of Good Documentation Practices (GDP) and Current Good Tissue Practices (cGTP) daily. This person will also assist with metric reporting for EM duties, data trending and analysis, investigation writing, and audit support.

What will you be doing?

• Performs microbiological monitoring duties including viable air, viable surfaces, and non-viable particulate sampling of clean room facility for routine monitoring.

• Receives, incubates, and reports results from environmental monitoring samples.

• Receives samples into QC and ships samples for testing to external labs.

• Performs water and steam sampling of USP water system.

• Initiates investigations for deviations and out of specification test results.

• Maintains required QC records and logs and performs cleaning of EM equipment and other preventative maintenance as required.

• Reviews/Trends/Archives data associated with environmental monitoring testing and reports anomalies.

• Perform gown certifications and review results of performance for personnel entering the cleanroom environment

• Report Environmental metrics for Quarterly review

• Participate in continuous improvement projects.

What will you need to be successful?

• Education:

• BS degree or 3 years relevant work experience preferred

• BS in scientific field required

• Experience:

• Minimum 1 year work experience within the biotechnology or pharmaceutical industry

• Proficiency in other compliance disciplines, i.e., cGTP, GLPs, GDP, GxPs

• Quality focused and results oriented with strong problem-solving abilities

• Ability to interact in a professional manner at all times

• Excellent organizational, written and verbal communication skills

• Ability to manage multiple and varied tasks and is able to prioritize workload

• Good documentation skills

• Flexibility and ability to adjust to changing priorities and unforeseen events; excellent time management skills

• Ability to work consistently in a fast-paced environment with little supervision

• Good interpersonal skills and the ability to work effectively and efficiently in a team environment.

• Ability to work flexible hours, including possible off-shifts and weekends.

• Material & Equipment Used & Frequency:

• PC computer software

• Daily

• Environmental monitoring equipment (viable and non-viable particle counter, incubator, etc.)

• Physical demands:

• Ability to get gown certified

• Ability to gown into clean room to perform environmental monitoring duties

• Ability to perform routine EM sampling off schedule

• Work Environment:

• Office, Cleanroom, and Lab Environment

• Core hours are M-F 9 am

• 5:30 pm, and you may occasionally be required to work earlier or later as needed

You. Unlimited

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

Inclusion, Diversity and Equity- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/ ).

Other reasons why you will love it here!

• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement

Work/Life Balance: PTO, Paid Holidays, Flex Holidays, Paid Community Service Day

• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program

• Training: Hands-On, Team-Customized, Mentorship

• Extra Perks: Discounts on fitness clubs, travel and more

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

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