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Quality Associate Specialist Job - United States  

Company managed [?] Still accepting applications

Posted on : 15 May 2017

Project Description

Quality Associate Specialist-QUA005851

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.


I. GENERAL SUMMARY:

The Quality System and Compliance Associate Release Specialist is responsible for document review and release functions that supports Durham VMF 101 and 102 formulation and filling facilities. The Associate Release Specialist must adhere to regulatory, global and site policies and procedures governing product release.

II. GENERAL PROFILE:

• Performs routine assignments in the entry level to a professional role

• Requires knowledge and exposure to cGMP and GDP

• Develops competence by performing applicable work assignments

• Uses existing procedures to solve routine or standard problems

• Receives instruction, guidance and direction from others

• Builds own team effectiveness skills and promotes team effectiveness through own actions by demonstrating respect and appreciation for diverse perspectives

III. BUSINESS EXPERTISE:

• Applies general knowledge of company business developed through education or past experience

• Understands and applies regulatory/ compliance requirements relative to their role

IV. FUNCTIONAL EXPERTISE:

• Basic conceptual knowledge and practices associated with Document Review and Product Disposition

• Essential Functions:

• Review and approve Culture Media, Filled Product, and Process Simulation Batch Records

• Execute review of electronic Master Batch Records (eMBR’s) utilizing reduced content review of critical steps and parameters as applicable

• Review and approve records from supplemental manufacturing operations through RtReports and autoclave logs.

• Provide Quality review and approval of fill product dilution models

• Work with Operations Team and Coaches to resolve issues identified during document review

• Present deviations at Event Notification meetings;

• Perform necessary SAP transactions to indicate task completions to support batch disposition decisions

• Additional Functions:

• Participate in process improvement or learning events, as guided or approved by Quality management

• Author, review, and approve SOPs

• Direct support of regulatory inspections and audits, as requested

• Other duties as requested by Management

V. PROBLEM SOLVING:

• Uses existing procedures to solve routine or standard problems

• Applies limited judgment and discretion

VI. INTERNAL CLIENT/EXTERNAL CUSTOMER FOCUS:

• Responds to standard requests from clients and/or customers

VII. IMPACT:

• Errors or lack of understanding of the job may cause delays in releasing material for use in Operations and to the end market

• Influence and Decision Making:

• Communicates information, asks questions and checks for understanding

• Has limited decision-making authority; works within technical guidelines and direction to achieve objectives and meet deadlines

VIII. PROJECT MANAGEMENT:

• Accountable for contribution to project team or sub-team

IX. RESOURCE MANAGEMENT:

• Builds awareness of costs related to own work

X. PHYSICAL REQUIREMENTS:

• Ability to sit, stand and move within work space for extended periods

• Ability to perform repetitive tasks

• Ability to lift up to 40 pounds

XI. WORKING RELATIONSHIPS:

• Reports to Quality Manager

• Interacts with employees within own department

• Frequent interaction with employees from other departments

• Interacts with representatives from regulatory agencies

Note: This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Qualifications

Education Minimum Requirement:

- B.S., B.A., or M.S. degree in Science, Engineering, Business or equivalent experience

Required Experience and Skills:

- Minimum of one year experience in pharmaceutical operations, technical services, and/or quality operations with at least Quality Control, Quality Assurance and/or cGMP experience

Preferred Experience and Skills:

- Knowledge of CFR, Eudralex and other regulatory guidance specific to the pharmaceutical industry

- Experienced in the methods and approaches of conducting quality 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: Quality Operations

Job Title:Assoc. Spclst, Quality

Primary Location: NA-US-NC-Durham

Employee Status: Regular

Travel: No

Number of Openings: 1

Shift (if applicable): 1st

Company Trade Name:Merck


Nearest Major Market: Durham
Nearest Secondary Market: Raleigh

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