Quality Control Lab Specialist
Location:
Wilson , North Carolina
Posted:
December 20, 2016
Reference:
QUA005310
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.

  • Completes a variety of testing to support release and stability requirements for a variety of products. Supports all areas of the laboratory, cross-training and providing testing support in various work cells as required. Provides training to other teammates and serves as subject matter experts.
  • Works with other Merck sites to ensure delivery schedules of samples to be tested are met.
  • Maintains compliance by following corporate policies/guidelines and local procedures. Identifies improvements to procedures and revises/trains others on the changes completed.
  • Supports and leads continuous improvement projects with minimal assistance and works to ensure sustainability of implemented changes identified through lean six sigma tools/activitites.
  • Identifies and implements changes focused on improving compliance performance in the laboratory.
  • Leads Tier I Activities and coordinates daily activities to ensure on-time, compliant testing is completed within their work cell. Actively participates in Tier II and, as needed, Tier III.
  • Demonstrates in-depth understanding of product performance and testing methodology. Able to train others on both.
  • Promotes an environment conducive with the 12 Inclusive Behaviors, actively promotes an inclusive culture and leads by example.
  • Ensures work is completed right first time. Leads root cause analysis and corrective action identification for deviation occurrences and properly documents investigations. Identifies proactive measures to ensure right first time achievement.
  • Leads remediation of monthly walk thru audits observations and works to ensure compliant operation of the laboratory to ensure successful outcomes of audits.
  • Works cross functionally to ensure proper prioritization/effective utilization of laboratory equipment.
  • Tests and interprets results for raw materials, active pharmaceutical ingredients, water, microbial limit testing, finished pharmaceutical products, and stability samples.
  • Interprets compendial and internal monographs, NDAs, CFR and Merck Quality Standards.
  • Provides technical and analytical support for cleaning validations, laboratory support requests, equipment validations, method transfers, and API Stability Packaging Description (ASPD).
  • Ensures laboratory compliance by adhering to cGMP, CFR, EU and other agency regulations.
  • Identifies improvement opportunities and both independently and as a facilitator of change, implements improvements. Learns a variety of tools to drive continuous improvement (lean six sigma, human error prevention, etc.).
  • Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents in the laboratory.
  • Maintains 5S organization throughout the laboratory and leads 5S activities to ensure compliance.
  • Provides guidance and coaching to new analysts within and outside his/her cell.



Qualifications:
Education:
  • B.A./B.S. degree (preferably in Science or Engineering)

Required:
  • Requires knowledge and experience in the Quality Control discipline and solves a range of straightforward problems. Analyzes possible solutions using standard procedures. Builds knowledge of the company, processes, testing and customers.
  • Receives a moderate level of guidance and direction and also proactively seeks advice/information from others when addressing serious business issues that may impact other functions.
  • Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group while contributing and adding value to the achievement of team goals.
  • Demonstrates a deep understanding of customer needs, requirements, and expectations. Continuously seeks new ways to improve services to customers and lean initiatives in the laboratory.
  • Speaks up on tough issues and occasionally challenges the status quo.
  • xpresses views and ideas at the right time while actively encouraging team members to make suggestions and share ideas.
  • Begins to effectively balance own point of view with new information and the perspectives of others while addressing conflict among peers and/or team members. Works to develop new skills and abilities.
  • Readily accepts performance feedback and incorporates this feedback into future performance.
  • Assists other team members, including helping with developmental activities. Learns to use new problem solving tools to surface and solve issues.
  • Good organizational and time management skills. Assists in direction of plant wide or department objectives.
  • Understands the fundamental business drivers for the company and uses this knowledge in own work and is proficient in multiple functional areas of the laboratory.
  • Ability to interpret Merck Quality Policies and Guidelines for daily application. Understands and applies regulatory/compliance requirements, including GMP, NDA, and related regulations, and has the ability to interpret those regulations for implementation in the workplace.
  • Possesses an expanded knowledge of theories, practices and procedures in the Quality Laboratory, including the knowledge and understanding of pharmaceutical testing.
  • Possesses strong technical writing capabilities and is able to compile more complex investigations, procedures, justifications, qualifications/validation protocols, etc.
  • Possesses an advanced knowledge and ability to operate multiple instruments required to complete job responsibilities with the ability to generate data and reports from these instruments.
  • Identifies and solves a range of problems in straightforward situations and analyzes possible solutions and assesses each using standard procedures.
  • Ability to independently respond to advances requests for data and trending of data and proactively utilizes trending of data to improve the operation or drive change.
  • Explains information and persuades others in straightforward situations.
  • Develops presentations which includes those needed to influence the actions and decisions of others and presents to own work team or large groups with limited assistance of others.
  • Makes decisions within guidelines and poilicies that impact own priorities and allocation of times to meet deadlines.
  • Recommends scientifically sound corrective and preventive actions.
  • Accountable for technical contribution to work or project team and may lead or manage a small project team.

Preferred:
  • 3-6 years of pharmaceutical industry experience required.
  • Managing Active Pharmaceutical Ingredients.
  • Strong knowledge and experience in HPLC analysis.

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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