Job Description

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Chemistry Manufacturing Control (CMC) Document Auditing Sr. Specialist reports to the Remediation Director, who reports to the Auditing and Remediation Executive Director, who reports to the head of Quality in Organons manufacturing division.

The Auditing and Remediation organization in Quality is responsible for managing pre and post regulatory inspection activities as well as routine auditing of internal sites, external suppliers and regulatory submissions.
Position Responsibilities:

* Independently audit applicable regulatory filing

* Track submission timelines to ensure deadlines are met while maintaining the highest level of Quality and Compliance

* Ensure compliance with regulatory expectations and internal Company requirements

* Work with functional areas to resolve audit findings. Effectively listen to the auditee and seek to understand differing perspectives to resolve audit issues.

* Identify need for and/or develop Standard Operating Procedures to ensure practices are accurately reflected

* Independently prioritize workload to meet aggressive timelines

* Support preparations for inspections

* Support Requests for Information from Health Authorities

* Constantly demonstrate leadership and interpersonal skills

* Share and apply lessons learned

Education Minimum Requirement:

* BS or BA in Sciences, Pharmacy, Engineering, or related field

Required Experience and Skills:

* Proficient in English

* Proven leadership with minimum of 5 years of experience in Quality and Compliance

* Knowledge of GMPs required

* Previous experience in regulatory submission filings

* Experience in successfully executing tasks with tight timelines

* Strong communication skills, written and oral, and attention to detail

* Strong technical skills

* Ability to build strong relationships

Preferred Experience and Skills:

* Manufacturing or Technical Operations experience from a plant site and/or Clinical expertise

Newco

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Remote Work, Telecommuting, Work Week

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

2
Requisition ID:R84896