VBF QA Specialist
Location:
RTP, NC
Posted:
January 27, 2017
Position Type:
Full Time
Category:
Quality Assurance
Reference:
QUA005526
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 Assurance Coordinator is responsible for all Quality related functions that directly support the Durham Integrated Process Team (IPT) within VBF (Varicella Bulk Facility) or VMF (Vaccine Manufacturing Facility) while actively supporting, participating in and embracing an empowered team culture. The IPT Quality Assurance Coordinator is responsible/accountable for Quality Assurance activities that support the VBF/VMF IPT, including periodic shop floor audits, direct in-line Quality support for all compliance and environmental monitoring (EM) matters, review and classification of atypical events including accessing product impact for EM events, providing Quality oversight to alarm events during processing, review and approval of incursions, review and approval of batch record documentation, along with review and approval of IPT related SOP's.

II. GENERAL PROFILE:
  • Requires working knowledge and experience in the discipline; still acquiring higher-level knowledge and skills
  • Builds knowledge of the company, processes and clients and/or customers
  • Solves a range of straightforward problems
  • Analyzes possible solutions using standard procedures
  • Receives a moderate level of guidance and direction
  • Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals
III. BUSINESS EXPERTISE:
  • Understands the fundamental business drivers for the company; uses this knowledge in own work
  • Understands and applies regulatory/ compliance requirements relative to their role
IV. FUNCTIONAL EXPERTISE:

The IPT Quality Assurance (QA) Coordinator role will be responsible for activities that support cGMP and regulatory compliance during product manufacturing within the respective VBF and VMF IPT's to include the following:
  • Direct in-line Quality support for all cGMP compliance, batch review, and environmental monitoring matters.
  • Review and approval of batch record documentation (electronic batch record comment resolution, RT reports, autoclave records, review and approval of electronic and paper batch records as applicable)
  • Sample management
  • Provide Quality oversight to alarm events (non-viable particles, differential pressure, temperature, and humidity) during processing
  • Review incursions into classified areas for process and environmental impact and approve accordingly
  • Conduct periodic shop floor audits to ensure cGMP compliance
  • Review and classification of atypical events including accessing product impact for EM events.
  • Ensure proper control of materials via product investigations
  • Assist regulatory groups by providing documentation to support the approval of licensure supplements and new product license registrations
  • Author and review SOPs specific to the IPT
  • Investigate OOS results and/or laboratory atypicals
  • Evaluate environmental data and OOS reports for adverse trends
  • Observe and audit media challenges
  • Other:
  • SOP development and review
  • Direct support of regulatory inspections and audits
  • Direct support of validation activities and all other associated quality functions
  • Other duties as requested by management
V. PROBLEM SOLVING:
  • Identifies and solves a range of problems in straightforward situations; analyzes possible solutions and assesses each using standard procedures
VI. INTERNAL CLIENT/EXTERNAL CUSTOMER FOCUS:
  • Responds to standard requests from clients and/or customers
VII. IMPACT:
  • Errors on the job may cause time delays and impact the work of others in own work group or potentially impact product disposition
  • Influence and Decision Making:
  • Represents Quality on the shop floor to influence cGMP compliance and ensure product quality.
  • Explains information and persuades others in straightforward situations
  • Makes decisions within guidelines and policies that impact own priorities and allocation of time to meet deadlines
  • Escalates potential cGMP or compliance issues effectively in a timely manner for proper resolution to ensure product quality
VIII. PROJECT MANAGEMENT:
  • Accountable for quality and/or technical contribution to project team or sub-team; may manage/lead a small project team
IX. RESOURCE MANAGEMENT:
  • Aware of costs and assists in controlling costs related to own work
X. QUALIFICATIONS:

A. Essential:
  • B.S., B.A., or M.S. degree in Science, Engineering, or equivalent experience
  • Minimum 3 -7 years experience in pharmaceutical operations, technical services, and/or quality operations with at least 2 years in a quality function or targeted training in quality to perform the defined responsibilities
B. Preferred:
  • Knowledge of CFR, Eudralex and other regulatory guidance specific to the pharmaceutical industry
  • Experienced in the methods and approaches of conducting environmental monitoring
  • Experienced in the methods and approaches of conducting quality audits
XI. PHYSICAL REQUIREMENTS:
  • Ability to sit, stand and move within work space for extended periods
  • Ability to aseptically gown
  • Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping pushing and pulling
  • Ability to travel
XII. 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
  • Interacts with external suppliers


Qualifications:
Education Minimum Requirement:
  • B.S., B.A., or M.S. degree in Science, Engineering, or equivalent experience
Required Experience and Skills:
  • cGMP in pharmaceutical industry; ability to aseptically gown, previous QA experience;
  • ability to work independently, previous paper batch record review experience
Preferred Experience and Skills:
  • knowledge of CFR regulations,

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:

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