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Senior Specialist, Quality Assurance Job

Employer
Merck
Location
West Point PA
Closing date
Mar 15, 2017

Job Details

Senior Specialist, Quality Assurance-CLI005674

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.


- Maintain an expert level of knowledge related to GMP requirements and industry trends as described in applicable worldwide regulations.

- Advice supported areas on requirements for all assigned project responsibilities as related to Quality and Merck Standards and communicate project status to management.

- Independently audit applicable regulatory filings. Ensure compliance with regulatory and Merck requirements. Work with areas to resolve any audit findings

- Identify training needs and oversee, develop and/or conduct training or orientation sessions for internal staff and client groups as well as staying current with own training requirements.

- Identify need for and/or develop SOPs to ensure practices are accurately reflected.

- Represent GMPQ on inter-departmental and cross-functional teams, ensuring the flow of information and providing quality guidance.

- Independently prioritize activities in support of multiple projects.

- Support preparations for regulatory agency inspections.

Lead Auditor Requirements include:

Consistently demonstrating Merck Leadership Behaviors:

Fosters Collaboration, Drive Results, and Make Rapid Disciplined Decisions.

Demonstrates excellent organization skills.

Can effectively manage multiple projects, and delegate audits to support team/auditors. Request additional resources as necessary.

Maintains positive working relationships within CMC auditing team and client areas.

Share and apply lessons learned.

Holds self and other accountable.

Clear communication skills (express in a clear, concise manner).

- Demonstrate interpersonal skills to effectively lead an audit.

- Attend Project Team Meetings

- Act as a single point of contact

- Provide links of CMC Audit SOPs and SPR trainings (QM SOP 5.01, SOP 840-2020, SPR Training Slides, RAS SOP 840-1019, Risk Based Protocols)

- Keep close track of submission timelines and meets deadlines while still maintaining all audit goals.

- Identify and manage issues on a continuous basis (e.g. unacceptable source documents, late submission of audit documents, and delay in comments resolution that impacts submission time lines.)

- Provide guidance to the project teams in specific situations in terms of sources, audit maps, and workflows.

- Update the auditing team with changes in Submission Timelines, or other changes (Specifications, Methods, etc.)

- Prioritize audit sections based on CMC’s request.

- Effectively listen to the auditee and seek to understand differing perspectives to resolve audit issues.

- Specific and/or additional duties may include, but are not restricted to:

− Provide tracking, trending and metrics for GMPQ auditing activities, Provide technical guidance to senior management in evaluating systems/tools. Assist GMPQ staff and client areas with the technical aspects related to the use of electronic audit tools.

Support Process Improvement initiatives for CMC client and auditing area

Qualifications

Education Minimum Requirement:

- B.S., M.S. and/or PhD. degree in a Science discipline.

Required Experience and Skills:

- Minimum of 5 years’ experience with B.S./M.S. / PhD.

- Experience in pharmaceutical/biotechnology, Computer, IT in a scientific quality or compliance role.

- Extensive working knowledge of cGMPs and technical aspects of support area are required. Effective communication, negotiation, problem-solving, and interpersonal skills with demonstrated project management abilities are necessary to perform job responsibilities. Previous experience required to perform job responsibilities may include: computer science, IT, quality assurance, auditing, or regulatory submission requirements.

Preferred Experience and Skills:

- Experience supporting Internal and/or external audits

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: Clinical, Non Clinical Quality Assurance

Job Title:Sr. Spclst, Quality Assurance

Primary Location: NA-US-PA-West Point

Other Locations: NA-US-NJ-Rahway

Employee Status: Regular

Number of Openings: 1

Shift (if applicable): 1st

Company Trade Name:Merck

Company

Our vision is to make a difference in the lives of people globally through our innovative medicines, vaccines, biologic therapies, consumer health and animal products. We aspire to be the best healthcare company in the world and are dedicated to providing leading innovations and solutions for tomorrow.

We have made it our mission to provide innovative, distinctive products and services that save and improve lives, satisfy customer needs and to be recognized as a great place to work

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