Specialist, Operational Quality Control

Regulatory Toolkit; Pennsylvania; In loco; USD 87.000 - 137.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Long-term incentive

Comprehensive benefits

Descrizione del lavoro

Regulatory Jobs in Pennsylvania seeks a Quality Specialist to support Micro Sterility Assurance testing under GMP, SOPs, and quality standards. You will review documentation, drive CAPA, and partner with lab and quality teams to improve compliance and efficiency.

This role supports process improvement initiatives through MPS and involves data integrity, deviations management, and collaboration across cross-functional teams. Eligible for bonuses and long-term incentives.

Competenze

• Bachelor’s degree in a life science field with GMP exposure.
• 1+ year in a GMP-regulated environment, preferably microbiology or sterility.
• Working knowledge of SOPs, deviations, investigations, and quality systems.
• Experience supporting laboratory testing and documentation review.
• Familiarity with continuous improvement tools and MPS principles.
• Strong attention to detail, organization, and analytical thinking.
• Effective communication and collaboration skills.

Mansioni

• Provide quality support to Micro Sterility Assurance lab operations and testing.
• Support sterility testing processes per GMP, SOPs, and quality standards.
• Review laboratory documentation and data for accuracy and compliance.
• Assist in deviation investigations and follow-up actions.
• Support quality system activities including change control, documentation review, and CAPA.
• Collaborate with lab and quality teams to resolve quality issues timely.
• Contribute to process improvement using MPS for efficiency and standardization.
• Participate in root cause analysis and problem-solving of quality events.
• Ensure data integrity and good laboratory documentation practices.
• Assist with internal audits, inspections readiness, and quality assessments.
• Monitor trends, identify recurring issues, and propose corrective actions.
• Help implement and maintain quality metrics and continuous improvement plans.
• Participate in daily tier meetings to review priorities and actions.

Conoscenze

Adaptability

Analytical Instrumentation

Analytical Method Development

CAPA Management

Continuous Improvement

Deviation Management

GMP Compliance

Laboratory Analysis

Quality Assurance

Trend Monitoring

Troubleshooting

Teamwork

Technical Writing

Formazione

Bachelor’s degree in Microbiology, Biology, Biochemistry, Chemistry, or related scientific discipline

Descrizione del lavoro

Job Description

Position Overview

The Quality Specialist supports the Micro Sterility Assurance Laboratory by providing quality and compliance oversight for sterility assurance testing activities. This role ensures laboratory operations are conducted in accordance with GMP requirements, approved SOPs, and company quality standards. The incumbent will support routine and non-routine Micro Sterility Assurance testing activities, review documentation for accuracy and completeness, and partner with laboratory and quality teams to drive continuous improvement. In addition, this position will support process improvement initiatives through MPS, helping identify opportunities to improve efficiency, compliance, and operational performance.

The Quality Specialist is expected to maintain a strong understanding of GMP, SOPs, deviations, and other quality system requirements, while ensuring work is completed accurately, consistently, and in compliance with regulatory expectations.

Essential Functions

• Provide quality support to Micro Sterility Assurance laboratory operations and testing activities.
• Support Micro sterility assurance testing processes in accordance with GMP, SOPs, and applicable quality standards.
• Review laboratory documentation, records, and data for accuracy, completeness, and compliance.
• Assist in deviation investigation, documentation, and follow-up actions.
• Support quality system activities including change control, documentation review, and CAPA where applicable.
• Partner with laboratory staff and quality representatives to ensure compliance and timely resolution of quality issues.
• Contribute to process improvement initiatives using MPS to improve laboratory efficiency, standardization, and compliance.
• Participate in root cause analysis and problem-solving activities related to laboratory quality events.
• Ensure adherence to data integrity, documentation practices, and good laboratory practices.
• Support internal audits, inspection readiness, and other quality-related assessments as needed.
• Monitor trends, identify recurring issues, and recommend corrective and preventive actions.
• Assist with the implementation and maintenance of quality metrics and continuous improvement plans.
• Participate in daily tier meetings to review priorities, accelerate issues, track action items, and support timely resolution of operational and quality concerns.

Qualifications

• Bachelor’s degree in Microbiology, Biology, Biochemistry, Chemistry, or related scientific discipline preferred.
• 1+ years of experience in a GMP-regulated environment, preferably in a microbiology or sterility assurance setting.
• Working knowledge of SOPs, deviations, investigations, and quality systems.
• Experience supporting laboratory testing and documentation review.
• Familiarity with continuous improvement tools and MPS principles preferred.
• Strong attention to detail, organizational skills, and analytical thinking.
• Effective communication and collaboration skills.
• Ability to work independently and within cross-functional teams.

Preferred Skills

• Experience in sterility assurance, microbiological testing, or quality assurance laboratory support.
• Understanding of CAPA, change control, and audit readiness processes.
• Ability to support process improvement and standardization efforts.
• Strong problem-solving mindset and commitment to compliance.

The role is part of a 7-day operation and may require flexibility to support business and laboratory needs.

Required Skills

Adaptability, Analytical Instrumentation, Analytical Method Development, CAPA Management, Continuous Improvement Techniques, Deviation Management, Deviation Reporting, Driving Continuous Improvement, GMP Compliance, Good Lab Practices, Inspection Readiness, Laboratory Analysis, Laboratory Documentation, Laboratory Quality Control, Laboratory Safety, Microbiological Analysis, Quality Assurance (QA), Quality Improvement, Quality Metrics, Sterility Assurance, Teamwork, Technical Writing, Trend Monitoring, Troubleshooting, Use of Laboratory Equipment

The primary location for this posting is:

USA - Pennsylvania - West Point

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$87,300.00 - $137,400.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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.

Additional location(s):

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

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

No Travel Required

Flexible Work Arrangements

Not Applicable

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

Yes

Job Posting End Date

11/12/2026

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.