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Quality Assurance Analyst Job - Elkton, VA

Date: Apr 20, 2015

Location: Elkton, VA, US

Company: Merck

Quality Assurance Analyst-QUA004058


Merck is a global health care leader with a diversified portfolio of prescription medicines, and vaccines, as well as animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Position Overview

Position carries out a variety of activities to support operations becoming familiar with site processes, procedures, and policies assuring alignment with cGMPs (current Good Manufacturing Processes) and Health Authority regulations. Conducts batch record reviews, audits, investigations, and helps with internal audits / external inspections. Supports sampling requirements for several areas. Performs quarantine functions and accountability reviews. Supports special projects as assigned. Follow cGMP and routinely makes decisions using cGMP/process knowledge. Works with customers to resolve problems and to satisfy quality and production needs. Performs regulatory document reviews and prepare regulatory or other required documents per local and divisional guidance. Follows site safety requirements. Authors, reviews, and or approves data and documents such as methods, procedures, and protocols. Completes assigned projects. Performs all work in a timely manner and is an active member of 1 or more teams. Tracks/reports metrics.

The open position is currently assigned to an aseptic, antibiotic filling line though assignment of work can apply across the antibiotic process (bulk existing and capital project) at the site.



* Required: Scientific Bachelor's degree (biology, engineering, other)

Required Experience:

* 2 years experience in Pharmaceutical Industry or Quality Assurance/Control

Preferred Experience:

* Demonstrated verbal/written communication and decision making skills

* Experience with GMP/compliance requirements for food or pharmaceutical industry

* Technical writing skills; understanding of computer system SAP and Office products; basic statistical understanding; sterile/aseptic processing experience

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at

Search Firm Representatives - Please read carefully:

Merck 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.

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

Job: Qual Assurance & Ops Generic

Job Title:Spclst, Quality Assurance

Primary Location: NA-US-VA-Elkton

Employee Status: Regular

Travel: No

Number of Openings: 1

Shift (if applicable): 1st

Hazardous Materials: Beta-lactam antibiotic

Nearest Major Market: Harrisonburg
Nearest Secondary Market: Virginia
Job Segment: Engineer, ERP, Law, Pharmaceutical, Quality Assurance, Technology, Engineering, Legal, Science

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