Quality Control Lab Support Associate Specialist

Job Description

Our Quality Assurance Group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

We are seeking a Growth and Improvement minded Quality Control Lab Support Associate Specialist that can help drive our Strategic Operating Priorities.

• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

• Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world

• Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

Summary, Focus and Purpose

Requires knowledge and experience in the Quality Control discipline and solves a range of laboratory problems. Analyzes possible solutions using standard procedures for laboratory issues. Receives a moderate level of guidance and direction while proactively seeking advice/information from others when addressing 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 service to customers and lean initiatives in the laboratory. Expresses views and ideas at the right time while actively encouraging team members to make suggestions and share ideas. 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 our Company 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, processes and procedures in the Quality Laboratory, including the knowledge and understanding of pharmaceutical Equipment Qualification, Calibration, Preventive Maintenance, Corrective Maintenance regulatory requirements and company procedures. Possesses technical writing capabilities and is able to compile complex investigations, procedures, justifications, qualifications/validation protocols, etc. Possesses an advanced knowledge and ability to master multiple instruments required to complete job assignments with the ability to sufficiently troubleshoot from these instruments.

Identifies and solves a range of problems in situations and provides possible solutions and assesses each using standard procedures. Ability to independently reply to requests for Lab problems and failures. 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 policies that impact own priorities and allocation of times to meet deadlines. Accountable for technical contribution to work or project.

Key Functions

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

• Supports all areas of the laboratory, cross-training and providing testing support in various work cells

• Provides information to lab chemists and serves as subject matter experts

• Works with PM mechanicals and or vendors to ensure Equipment Qualification and Calibration on time of schedule, protocols and process

• Accountable for lab equipment validation, maintenance, correct operation, and correction as needed (ex: glasswashers, sample storage chambers, etc.)

• Maintains compliance by following corporate policies/guidelines and local procedures. Identifies improvements to procedures and revises/trains others on the changes completed

• Identifies and implements changes focused on improving compliance performance in the laboratory

• Demonstrates in-depth understanding of equipment performance and usage methodology

• Able to train lab chemists and teammates as a SME (SME of Empower, Global Laboratory Information Management System (GLIMS), and other systems used by the laboratory)

• Promotes an environment conducive with the 12 Inclusive Behaviors, actively promotes and inclusive culture and leads by example

• Leads root cause analysis and corrective action identification for deviation occurrences and properly documents investigations and identifies proactive measures to ensure right first-time achievement

• Supports remediation of walk thru audit 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

• Interprets and applies compendial and internal monographs, NDAs, CFR and our Company Analytical Standards, if applicable

• Provides technical and analytical support for cleaning validation, 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 tolls to drive continuous improvement (ex. lean six sigma, human error prevention, etc.)

• Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents in the laboratory

• Understand and applies Data Integrity concepts in depth within our Company Data Integrity Center of Excellence

Education

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.

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.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Residents of Colorado:

Click here to request this role’s pay range.

Learn more about your rights, including under California, Colorado and other US State Acts

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R229265