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Senior Quality Systems Specialist Job - United States  

Company managed [?] Still accepting applications

Posted on : 10 April 2017

Project Description

Senior Quality Systems Specialist-REG002836

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. 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 an individual 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.


The incumbent will be part of a high thru-put team focused on ensuring accurate change control documentation with appropriate technical support, adequate material controls are in place and ensures standard implementation at the sites. The incumbent will be providing functional support for activities such as: In-line products, packaging, outsourcing, divestitures, method development and validation, analytical compliance, Analytical Standards, compendiaI compliance, quality assurance, etc. Provides customer support to MMD manufacturing sites and laboratories, other analytical groups, MRL, Technical Operations, Joint Ventures, etc. Performs the appropriate document review and support activities associated with their position and ensures their work is in compliance with all regulatory expectations. The incumbent is also responsible for the application of, and conformance to current Good Manufacturing Practices (cGMP).

Primary Activities Primary activities include, but are not limited to:

1. Ensures that all Analytical Standard documents are written clearly and unambiguously,are maintained in accordance with established divisional and departmental procedures,and issued in a timely fashion. Maintains product,active ingredient,intermediate, raw material,and component Analytical Standards. This may include, but is not limited to addition/deletion/modification to analytical methods, specifications, product numbers, product descriptions,and editorial changes. Provides Analytical Standard support and coordination for new product introductions and registrations. May participate in product teams (e.g. IDST, AST Quality Subteam) and participates in activities associated with the development of line extention or new products..

2. Performs the evaluation, disposition and implementation of all Analytical Standard changes/modifications in accordance with the Analytical Change Control {ACR) process. Evaluates and investigates ACRs to determine impact and appropriateness,collaborating with subject matter experts and stakeholders as necessary. Performs the activities of an ACR coordinator when required).

3. Provides support to the MMD Quality Standard/Compendia! customers. Participates in activities and provides appropriate support to Merck Network Sites as well as business partners {P3) in accordance to the approved supply agreements/contracts.

4. Demonstrates continuous improvement though the ability to optimize functional performance and teamwork through the relentless pursuit and application of standards, best practices, appropriate tools, to positively impact individual and organizational performance, quality, and outcomes for delivery of value and competitive success.

5. Ensures the review, approval and issuance of Quality Standards are performed in a timely manner and in compliance with departmental practices and GMP regulations. Performs the required Quality approvals of draft Quality Standard documents to progress to QS issuance.

6. Provides guidance to other staff members.

Qualifications

Education Minimum Requirement:

- BS/MS in Chemistry, Biology or related science in a relevant discipline.

Required Experience and Skills:

- BS with minimum of 4 years experience or MS with 2 years post degree experience.

- Requires high level of technical knowledge and aptitude.

- Requires appropriate laboratory experience,knowledge of laboratory operations and analytical instrumentation.

- Requires ability to work independently and on teams,managing multiple projects/tasks simultaneously with competing priorities;managing meetings effectively, providing customer support, managing time and personal effort.

- Requires ability to think originally and imaginatively in developing creative ideas.

- Possess the skills to persuade and motivate others.

- Requires superior written and oral communications skills, advanced problem solving and proficient decision making skills.

- Proficient computer skills.

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. Our Company’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 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: Regulatory Affairs Generic

Job Title:Sr. Spclst, Regulatory Affairs

Primary Location: NA-US-PA-West Point

Other Locations: NA-US-NJ-Whitehouse Station West

Employee Status: Regular

Number of Openings: 1

Shift (if applicable): 1st

Company Trade Name:Merck


Nearest Major Market: Philadelphia

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