Specialist, Quality Control Execution Support (2nd Shift)

HireLifeScience

West Point (PA)

On-site

USD 87,000 - 137,000

Full time

5 days ago

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Benefits offered by this job

Annual bonus

401(k) plan

Medical insurance

Paid time off

Job summary

HireLifeScience is hiring a Quality Control Execution Support Specialist (2nd shift) to manage analytical method lifecycles and support transfers, validations, investigations, and tech rationale. This role requires collaboration with QC and Manufacturing and focuses on separations, biochemistry, and microbiology.

The position demands on-site, 5-day-a-week support for QC labs, with opportunities to influence regulatory readiness and audits through strong technical documentation and

Qualifications

Bachelor's degree in Chemistry, Biology, Microbiology or related field.
1+ years on analytical method introduction and qualification in biopharma/pharma.
Experience with HPLC, ELISA, PCR and microbial methods.

Responsibilities

Support end-to-end lifecycle of analytical methods and tech transfers.
Provide SME assessment for method/equipment qualification and investigations.
Train end users and support regulatory responses.
Lead change controls and lifecycle management of methods.
Perform analytical method troubleshooting and cross-functional reviews.

Skills

Analytical Method

Analytical Thinking

Change Management

GMP Compliance

Laboratory Documentation

Data Analysis

Problem Solving

Communication Skills

Education

Bachelor's degree in Chemistry/Biology/Microbiology

Tools

HPLC

cGE

ELISA

Bioassays

PCR

Microbial methods

Job description

Job Description

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.

Purpose of Role:

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.

This role will require 5 day a week on site support for 2nd shift QC Laboratory Operations.

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.

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

Salary and Benefits

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 .

Location Specific Policies

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

Travel Requirements

10%

Flexible Work Arrangements

Not Applicable

Shift

2nd - Evening

Valid Driving License