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 Associate Laboratory Specialist within the Quality Assurance Center of Excellence, with guidance from the Associate Director of Quality Assurance, provides Quality support to Laboratory Operations. The Associate Laboratory Specialist will review laboratory data to ensure that all laboratory data is maintained in accordance with prescribed specifications, procedures and Good Documentation Practices. Data review will include the evaluation of raw data as well as verification of final data integrity (i.e., calculations, adherence to SOPs, BATs, BLPs, Compendia).
The Associate Laboratory Specialist will represent quality on the shop floor and perform documentation accuracy and completeness checks while on the shop floor. He or she will work closely with the assigned laboratory in a team environment to ensure timely reviews of documentation and to ensure that documentation is completed right the first time. The Associate Laboratory Specialist will work with Laboratory Operations staff and management to remediate comments and errors in documentation. He or she may also assist Laboratory Operations in conducting investigations associated with laboratory data review. Additionally, the Associate Laboratory Specialist will utilize time on the shop floor to partner with Laboratory Operations and technology to enable right first time testing, to learn the analytical processes, and to ensure compliance with cGMPs and regulatory requirements.
The Associate Laboratory Specialist will also be trained to support Quality Assurance system functions and to support End to End Quality Operations as needed.
Primary Activities include but are not limited to:
1. Present on shop floor to provide compliance support and to learn testing procedures, analytical processes and Merck Quality Systems
2. Actively participate in the Tier process and use this forum to make concerns visible and to partner with Laboratory Operations on resolution.
3. Responsible for the independent auditing of laboratory data in alignment with the policies of the department, division, company and other applicable mandates. Maintain the highest level of proficiency in terms of those duties and responsibilities required of auditors.
a. Maintain metrics and tracking associated with these documentation reviews.
b. Complete the remediation activities for all data reviews, to ensure errors are appropriately corrected and documented following departmental and site procedures.
4. Ensure the laboratory data is in compliance with cGMPS, GLPs, and departmental procedures and assay methods and is of the highest integrity, quality and accuracy.
5. Responsible for issuance of new and reconciliation of completed laboratory worksheets
6. Foster a customer service attitude within Laboratory Operations.
7. Review laboratory notebooks, logbooks, and CTU records to ensure compliance to data integrity and accuracy.
Provide support to Regulatory Agency Inspections as needed. Qualifications: Education Minimum Requirement:
Preferred Experience and Skills:
- •Bachelors degree. Degree in life science, scientific discipline or engineering preferred OR M.S. degree in life science, scientific discipline or engineering
- In lieu of a Life Sciences or other Bachelors degree, equivalent, direct experience of 4 years working in a GMP environment, direct experience with Documentation Review and/or Control, or prior experience supporting Regulatory Agency Inspections is required
- Experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting.
- Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment.
- Demonstrated analytical aptitude, critical thinking skills, and problem solving.
- Demonstrated ability to upskill / coach others.
- Strong written and verbal communication skills.
- Experience in pharmaceutical laboratory operations or related environment.
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 firstname.lastname@example.org. 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.
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