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Form of workJob Description
Responsible for daily operation of laboratory cells including coordination of testing and data review to meet due dates. Participates in continuous improvements, lean activities, kaizens and KATA methodology. Performs Quality sampling, testing, and release for bulk raw materials, active pharmaceutical ingredients, water, microbiological limits, primary packaging components and finished pharmaceutical products.
Primary Responsibilities
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 company 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/activities.
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 our Company 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.
Performs Purified/Potable Water sampling and testing.
Performs Compressed Air Utility sampling and testing.
Performs Environmental Monitoring sampling and testing.
Performs Microbial Enumeration Testing per USP
Position Qualifications:
Minimum Education Requirements
B.A./B.S. degree (preferably in Science or Engineering)
Required Experience and Skills
Minimum 3 years of pharmaceutical manufacturing industry experience
Microbiology and Environmental Monitoring experience
Knowledge of regulatory/compliance requirements, including GMP, NDA, and related regulations
Preferred Experience and Skills
Purified/Potable Water sampling and testing.
Compressed Air Utility sampling and testing.
Environmental Monitoring sampling and testing.
Microbial Enumeration Testing per USP
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
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:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not SpecifiedShift:
1st - DayValid Driving License:
NoHazardous Material(s):
N/ARequisition ID:R266808
