Specialist, Quality Control Execution Support (2nd Shift)

CamWebDir; West Point (PA); On-site; USD 87,000 - 137,000; Full time

Job summary

Merck in West Point, PA is hiring a Quality Control Execution Support Specialist for the 2nd shift to manage end-to-end analytical method lifecycles, including new method introductions, transfers, and regulatory responses. The role emphasizes technical leadership, cross-functional collaboration, and process improvements within QC labs.

Ideal candidates have a chemistry/biology/microbiology background, 1+ year experience in analytical method intro/qualification, and strong project management and

Qualifications

• Bachelor's or Master’s in Chemistry, Biology, Microbiology or related field.
• 1+ years analytical method introduction and qualification experience in biopharmaceutical/pharmaceutical industry.

Responsibilities

• Support end-to-end method lifecycle management including transfer, validation, and tech transfer receiving lab support.
• Act as SME for regulatory questions, audits, and regulatory submissions support.
• Develop and own change controls for updates to analytical methods and compendial changes.
• Provide training to QC and Manufacturing staff on lab systems, processes and methods.

Skills

Analytical Method Development

Analytical Instrumentation

Data Analysis

Change Controls

Coaching

Regulatory Submissions

Communication Skills

Project Management

Education

Bachelor's degree in Chemistry/Biology/Microbiology

Master's degree (optional)

Tools

HPLC

cGE

ELISA

PCR

Bioassays

Job description

Job Description

Purpose of Role:

The Quality Control Execution Support Specialist role (2nd shift) is responsible for supporting Analytical Procedure Life Cycle through end-to-end method lifecycle management including introduction of new analytical methods, act as the receiving unit for analytical transfers, SME assessment for all analytical method & equipment performance qualification, investigations, product testing and technical rationale. This work will support pipeline and commercial products by utilizing expertise in the analytical areas of separations, biochemistry, and microbiology.

Activities Within Role:

• New method introduction (Direct to QC Validations /Tech Transfer Receiving Lab Support).
• New technology introduction.
• Assessment and implementation of changes for existing methods and equipment:
  • Change in technical element of method e.g. Parameter change
  • Change in equipment element of method e.g., column/reagent change.
• Method troubleshooting where cross-functional investigation is required.
• Technical SME for regulatory questions, audit support, reagent changes / supply issues to provided justification / rationale for analytical methods and equipment.
• Technical review of impact on Analytical methods and equipment as part of cross-functional team assessment of new/revised Global Test method / Compendia changes or updates.
• Analytical equipment troubleshooting.
• Initial training of end users in QC and Manufacturing and training of site analytical sciences personnel on lab systems, processes and methods where agreed.
• Investigation support for lab investigations.
• Authoring technical documentation in support of investigation and regulatory responses.
• Analytical impact assessors on all QC Lab OPS change controls.
• Technical Impact Assessment of proposed and finalized compendial changes.
• Development and ownership of change control for updates to analytical methods.
• Routine Assay Monitoring and lifecycle management of analytical methods.
• Supporting digital method development.

Continuous Improvements:

Responsible for driving a culture of Continuous Improvement by deploying our Company Six Sigma tools

Coaching and Training:

The Analytical Sciences Team Lead will provide support, guidance, and expertise to ensure the success of the Analytical Sciences group; will model our Company Leadership behaviors and understand the MPS principles to drive a culture of continuous improvement building a High-Performance Organization.

Reports to:

West Point Site Analytical Sciences, Quality Control Execution Lead

Behaviors, Job Experience and Qualifications

Key Behaviors:

• Win as one team.
• Focus on what matters.
• Act with urgency.
• Experiment, learn and adapt.
• Embrace varied perspectives and inclusion.
• Speak Up and be open-minded

Required Education.

• Bachelor's degree (1-3 years related work experience) or Master's degree (0 years related work experience) – in Chemistry, Biology, Microbiology or related field.

Required Experience & Skills.

• 1+ years working on analytical method introduction and qualification within the biopharmaceutical and/or pharmaceutical industry.
• Experience with analytical methods (HPLC, cGE, ELISA, Bioassays, PCR, compendial methods, Microbial methods, cell-based assays)
• Flexible, self-motivated & ability to manage multiple priorities.
• Strong project management and stakeholder management skills required with demonstrated ability to influence across internal and external stakeholders.
• Proven ability to work as part of an interdependent team but also on own initiative to ensure progression of priorities.
• Experience in problem solving (facilitation & application of tools), risk management, decision making & trouble shooting skills.
• Excellent communication skills – verbal, written, presentations.
• Ability to coach and support development of AS&T Scientists and QC technicians within AS&T and QC teams.
• Provide leadership and expertise for preparation of regulatory submissions, inspection readiness, and support health authority inspections – including but not limited to interaction with inspectors, responding to observations and monitoring of commitments.

Required Skills:

Adaptability, Adaptability, Analytical Instrumentation, Analytical Method, Analytical Method Development, Analytical Thinking, Change Controls, Change Management, Coaching, Competency Development, Data Analysis, Decision Making, Dissolution Testing, Driving Continuous Improvement, ELISA Test, Equipment Implementation, GMP Compliance, Influencing Skills, Karl Fischer Titrations, Laboratory Documentation, Laboratory Reports, Laboratory Safety, Laboratory Testing, Method Improvement, Microbiological Analysis {+ 12 more}

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.

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

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

2nd - Evening

Valid Driving License:

No

Hazardous Material(s):

N/A

Salary

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.