Specialist, Quality Systems & Compliance

  • Company: Merck
  • Location: Millsboro, Delaware
  • Posted: January 21, 2017
  • Reference ID: QUA005524
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.

The Quality Specialist ensures product/process quality via quality system adherence and batch record review. The Quality Specialist completes quality checks and SAP transactions required to release product. The Quality Specialist performs process document/logbook audits for accuracy and completeness and works closely with IPT in a team environment to ensure timely review and documentation is Right First Time (RFT). He or she provides support to include oversight for adherence to cGMPs,

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. The Quality Specialist performs job functions within a team environment. Specific responsibilities may include but are not limited to the following:
  • Performs Quality batch record review and approval
  • Performs Quality review and approval of master batch record updates
  • Performs critical site reviews for per process environmental monitoring
  • Collaborates with Planning, Operations and Technology organizations to ensure batches are ready for release by appropriate due dates
  • Performs Quality review and approval of new and updated SOPs and Controlled Job Aids
  • Performs GMP walk through inspections of assigned departments within the IPT to ensure compliance with cGMPs and regulatory requirements Assistance with external audits may also be required.
  • Assists with training of incoming personnel and ensures compliance with departmental procedures
  • Assists in validation activities including protocol development.
  • Assists in execution of aseptic process media simulation activities.
  • Actively participates in the Tier process and uses this forum to escalate concerns and best practices
  • Collaborates with Quality and IPT members in the identification and implementation of continuous improvement initiatives and action plans
  • Assists in the management and execution of critical quality systems such as change control, document management, Deviation management, etc.

  • Minimum of a Bachelor's degree is required (Scientific or Engineering field is preferred). Degrees in other fields of study will be considered if accompanied by significant relevant experience.
Required Experience and Skills:
  • At least two years of relevant post-degree work experience in a laboratory, manufacturing, or Quality position.
  • Evidence of leadership skills coupled with good oral and written communication skills.
  • Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.
Preferred Experience and Skills:
  • Familiarity with GMP documentation review is a key skill necessary for success in this position.
  • Experience in quality assurance audits or inspection of vaccine or pharmaceutical manufacturing areas is preferred.

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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