Specialist, Quality Control

Job description

Job Description The Laboratory Specialist within the Quality Operations department, with guidance from the Associate Director of Quality Operations, provides support to Laboratory Operations. The Laboratory Specialist will support sample tracking and scheduling, perform performance trends, manage inventory, facilitate collaboration meetings, engage in project work, and support other business needs at the direction of the Associate Director. The Laboratory Specialist will work closely with the assigned laboratory in a team environment to ensure timely turnaround of laboratory testing and to ensure that documentation is completed right the first time. The Laboratory Specialist will work with Laboratory Operations staff and management coordinate day-to-day schedule and perform historical performance trends. They may also assist Laboratory Operations in conducting investigations associated with sample scheduling or other related topics. Additionally, the Laboratory Specialist will also support project work as needed and lead collaboration meetings within the department and participate in those outside the department. The Laboratory Specialist will also be trained to support Quality Assurance system functions and to support End to End Quality Operations as needed. Primary Activities: Responsible for the scheduling of lab testing and performing sample tracking from receipt to approval. Maintain metrics and tracking associated with this testing and approval. Complete remediation activities for all samples, to ensure roadblocks are appropriately corrected in a timely manner. Actively participate in the Tier process and use this forum to make concerns visible and to partner with Laboratory Quality on resolution. Facilitate collaboration meetings with the Quality team to drive on-time testing and participate in meetings with external customers to provide testing updates. Collaborate with team members in the identification and implementation of continuous improvement initiatives and action plans. Support activities in the areas of cost containment, efficiency, productivity, energy conservation, waste minimization, operational excellence, and lean practices. Work with members from Quality and Technical Services to properly handle unplanned events impacting laboratory samples. Maintain media inventory. Participate in design and implementation of training and development programs. Foster a customer service attitude across the network. Assist with training of incoming personnel. Provide support to Regulatory Agency inspections as needed. Develop, Update and Modify SOP’s as needed. Education: ▪ Bachelor’s Degree in life science, scientific discipline or engineering preferred OR M.S. degree in life science, scientific discipline or engineering. Required Experience and Skills: ▪ Minimum 1-2 years' 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. Preferred Experience and Skills: 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 skills. Demonstrated ability to upskill / coach others. Strong written and verbal communication skills. Strong organizational skills. Experience in pharmaceutical laboratory operations or related environment Required Skills: Adaptability, Analytical Instrumentation, Biological Sciences, Driving Continuous Improvement, GMP Compliance, Laboratory Documentation, Laboratory Safety, Problem Solving, Teamwork, Technical Issues, Troubleshooting, Use of Laboratory Equipment, Written Communication Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $87,300.00 - $137,400.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 07/20/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end