RockvilleMDRecruiter Since 2001
the smart solution for Rockville jobs

Senior Quality Specialist, Quality Excellence

Company: Merck KGaA
Location: Rockville
Posted on: September 13, 2020

Job Description:

Experience the joy of curiosity, search for a job Click here for additional search options

Senior Quality Specialist, Quality Excellence Your Role:

As a Senior Quality Specialist in the Quality Excellence function, you will be responsible for activities that drive global Quality improvement. These will include activities such as driving inspection readiness, global simplification and standardization projects, authoring, reviewing and approving controlled documents to comply with appropriate regulations. Reporting to the Head of Quality Excellence, you will also play a key role in influencing and collaborating with stakeholders across multiple geographies, ensuring alignment and participation in these activities to deliver robust global implementation plans.

In addition to routine quality activities in a GXP environment, and as part of the Quality Excellence team, you will also:

Provide global support for regulatory inspections (including pre/post activities)

Drive standardization practices across the organization and champion procedure/process simplification

Conduct laboratory inspections to include inspection readiness, commissioning and/or internal audits

Champion the use and implementation of electronic records & other digital solutions

Provide quality direction and support for initiatives driven by Quality Excellence

Ability to travel (up to 20%) to other PSS sites located in US, EU and APAC

Who You Are:

Minimum Qualifications:

Bachelor’s degree in a scientific or technical discipline (i.e. Biology, Biotechnology, Chemical Engineering, etc.)

4+ years’ experience working in a cGMP Quality role

Preferred Qualifications:

Track record of quality improvement and execution

Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity etc.)

Previous experience of participating in, and knowledge of, global agency inspection programs for the biopharmaceutical or biotechnology industry such as US FDA, EMA, TGA, MHRA etc.

Previous experience of driving/leading projects in a global environment

Demonstrated proficiency in communication, written/verbal and interpersonal skills

Advanced degree (i.e. Master’s degree) in a scientific or technical discipline (i.e. Biology, Biotechnology, Chemical Engineering, etc.)

Knowledge of Project Management tools and track record of successful project implementation


Job Requisition ID: 208884

Career Level: D - Professional (4-9 years)

Working time model: full-time

US Disclosure

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure

The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

Keywords: Merck KGaA, Rockville , Senior Quality Specialist, Quality Excellence, Other , Rockville, Maryland

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Other Jobs

Amazon Order Picker - Part Time
Description: Seasonal Part-time Warehouse Team Member - 500 bonus br br Hourly pay rate: br br Earn 15/hr or more, plus benefits and a 500 bonus. br Limited-time opportunity. br br Location: br (more...)
Company: Amazon Workforce Staffing
Location: Lancaster
Posted on: 09/18/2020

CACI International: Cyber Engineer (Intel)
Description: Job DescriptionWhat Youll Get to Do:You will support the sponsors environments with risk assessment and the establishment amp execution of mitigationstrategies throughout the life cycle of the operational (more...)
Company: CACI International
Location: Chantilly
Posted on: 09/18/2020

Seasonal Amazon Warehouse Worker Up to $500 sign on bonus (Elizabethtown)
Description: br br Seasonal Warehouse Team Member - 500 Sign-On Bonus br br Hourly pay rate: br br Earn 15.55/hr or more, plus benefits and a 500 bonus br Limited-time opportunity. br br Shifts: (more...)
Company: Amazon Workforce Staffing
Location: Lancaster
Posted on: 09/18/2020

General Manager
Description: Long standing and successful company seeking dynamic General Manager to oversee all aspects of community association management business. The ideal candidate should be a thoughtful leader with a proven (more...)
Company: Patriot Properties
Location: Leesburg
Posted on: 09/18/2020

Ground System Software Engineer
Description: Job ID: 2014852 Location: CHANTILLY , VA , US Date Posted: 2020-09-15 Category: Engineering and Sciences Subcategory: Systems Engineer Schedule: Full-time Shift: Day Job Travel: (more...)
Company: SAIC
Location: Chantilly
Posted on: 09/18/2020

Systems Engineer Cloud DevOps Job posting in #Chantilly #ITjobs
Description: Technology is constantly changing, and our adversaries are digitally going dark at a rate that is exceeding law enforcement's ability to keep pace. Those charged with protecting the United States are (more...)
Company: Peraton
Location: Chantilly
Posted on: 09/18/2020

Amazon Warehouse Operator (Full-Time)
Description: Shifts: Overnight, Early Morning, Day, Evening, Weekend Location: Springfield, Arlington, Washington DC, Ashburn, Sterling Job opportunities vary by location. We update postings daily with open (more...)
Company: Amazon
Location: Chantilly
Posted on: 09/18/2020

Sr Systems Engineer I
Description: Are you looking for an engineering career that is challenging and satisfying Then join Raytheon Technologies team of engineers solving problems that make the world a safer place and help to secure our (more...)
Company: RTX
Location: Chantilly
Posted on: 09/18/2020

Data Scientist Sr Principal
Description: By providing the information below and checking the boxes referenced, you acknowledge and consent to SAIC's Privacy Policy to include access and use of your information for the purposes of sharing your (more...)
Company: SAIC
Location: Chantilly
Posted on: 09/18/2020

Systems Engineer
Description: Veteran Owned Firm Seeking a Systems Engineer with a CI Poly to support a client in Chantilly, VA My name is Stephen Hrutka, and I am the owner of a Veteran-owned firm in Washington, DC focused on Supply (more...)
Company: HRUCKUS
Location: Chantilly
Posted on: 09/18/2020

Log In or Create An Account

Get the latest Maryland jobs by following @recnetMD on Twitter!

Rockville RSS job feeds