Environmental Monitoring Laboratory Analyst Job

Employer
Merck
Location
Durham, NC, US
Posted
September 15 2017
Discipline
Other
Organization Type
Pharma
Environmental Monitoring Laboratory Analyst-QUA006253

Description

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

Specific to Environmental and Utility Monitoring, the Analyst will be responsible for maintaining the EM program to include
the following:
- Collection and testing of qualified Utility systems including Clean Steam, WFI and compressed gases.
- Execute environmental sampling of Classified Areas including active air sampling, surface sampling and non-viable air
sampling.
- Provide data entry and review as required.
- Provide summaries of test results to appropriate personnel as needed.
- Compile and evaluate environmental data for adverse trends.
- Directly support Performance Qualification activities.
- Perform routine monitoring of Personnel.
- Author and assist in Quality Notifications (QNs) investigations and product impact assessments.
- Review OOS report daily and notify Quality and Operations of required steps following OOS.
- Perform quarterly microbial testing and provide results/performance to Operations.
- Compile and author Annual Reviews
- Author and summarize Requalification, Performance Qualification, and Special Study protocols.
- Perform monthly and weekly sample accountability.
- LIMS sample rejections.
- Equipment Calibration and Management
- Filing data sheets and document control of logbooks
- Perform LIMS Change Controls
- Participation in Kaizen events
- SOP development and review.
- Direct support of regulatory inspections and audits.
- Direct support of validation activities and all

Qualifications

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

Education:
- Bachelor’s Degree in Microbiology, Biology, Biochemistry, Chemistry or other relevant discipline

Required:
- Quality Control, Quality Assurance and/or cGMP experience
- Minimum of 1 year of experience in environmental sampling of Classified Areas including active air sampling, surface
sampling and non-viable air sampling.
- Minimum of 1 year of experience in collection and testing of qualified Utility systems including Clean Steam, WFI and/or compressed gases

If you need an accommodation for the application process please email us at staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​



Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Quality Operations

Job Title:Assoc. Spclst, Quality

Primary Location: NA-US-NC-Durham

Employee Status: Regular

Number of Openings: 1

Shift (if applicable): 1st

Hazardous Materials: No

Company Trade Name:Merck