Quality Specialist, MMR Bulk Operations Support Job

Employer
Merck
Location
West Point, PA, US
Posted
August 11 2017
Discipline
Other
Organization Type
Pharma
Quality Specialist, MMR Bulk Operations Support-QUA006131

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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Quality Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model. Execution of the activities and responsibilities related to this position are designed to further develop the knowledge and skill foundation required to advance to other Quality-based functions within the organization.

The Quality Specialist, with guidance from the Quality Manager or IPT Quality Lead, ensures product / process quality, performs activities to facilitate the release of product to the marketplace, and ensures proper control of material.

The Quality Specialist is knowledgeable in federal and other regulatory agency requirements and cGMPs to ensure that all areas are in compliance, and will train on and gain competency in activities to ensure quality and compliance of product manufactured by the functional area. Specific responsibilities include but are not limited to the following:

1. Becomes fully trained in Merck Quality SOPs, production SOPs as needed, and SAP functions as required by Quality Specialists.
2. Learns cGMPs, the manufacturing process, and Merck quality systems.
3. Performs audit of process documents/logs to ensure completely and accuracy for the assigned IPT.
4. Coordinates with cross functional teams within the IPT (including but not limited to deviation management, environmental monitoring, and inspection support) to discuss, resolve, and eliminate documentation/execution defects and outstanding issues from the manufacture or testing of the batch (e.g., batch record review, investigations, testing, CRs, etc.) to ensure the timely submission/release of the material.
5. Ensures compliance with departmental procedures.
6. Actively participates in the Tier process and uses this forum to escalate concerns and best practices.
7. Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans.
8. Ensure proper identification of release status and control of materials through maintenance of batch and stock status in SAP and through physical tagging of material as required.
9. Assists with training of incoming personnel.
10. Completes training to become a qualified auditor and complete monthly internal quality audits often manufacturing areas.

Qualifications

Education Minimum Requirement:

Bachelor's degree. Technical emphasis in an appropriate scientific or engineering field preferred; candidates with majors in other fields will be considered if accompanied by significant relevant experience.

Required Experience and Skills:

• A minimum of one year of relevant post-degree work experience in GMP-related field, including Technical, Engineering, Quality or Operations.
• Evidence of leadership skills coupled with good oral and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.
• Effectiveness and creativity in approaching and solving technical problems
• Attention to detail, flexibility and an awareness of production and quality control problems.
• Experience working in a cGMP environment and application of regulatory requirements as they pertain to the pharmaceutical field or a related area.
• Basic understanding of the use and maintenance for Microsoft applications (such as MS Excel, Outlook, and/or MS Access)

Preferred Experience and Skills:

• Familiarity with vaccine and/or pharmaceutical processing.
• Familiarity with batch disposition (release) activities is a strongly preferred skill necessary for success in this position; prior batch disposition experience is a plus.

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

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: Quality Operations

Job Title:Spclst, Quality

Primary Location: NA-US-PA-West Point

Employee Status: Regular

Number of Openings: 1

Company Trade Name:Merck