GMP Equipment Scientist

Insight Global; Malvern (Chester County); On-site; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a Qualification Analyst to join their Equipment Lifecycle Management team. This role involves ensuring compliance with Quality Control procedures for GMP analytical instruments in a dynamic pharmaceutical environment. The ideal candidate will have a strong background in troubleshooting and qualifying GMP equipment, alongside a go-getter attitude and proficiency in Microsoft Office. You'll have the opportunity to draft essential protocols and collaborate with cross-functional teams, making a significant impact on the quality assurance processes. If you're passionate about the pharmaceutical industry and ready to contribute to innovative projects, this position is perfect for you.

Benefits

10 Days of PTO

6 Sick Days

Paid Holidays

Healthcare benefits

401k retirement account with matching

Paid sick leave

Qualifications

• 4+ years in Quality GMP environment with troubleshooting experience.
• Strong experience in qualifying GMP instrumentation and technical writing.

Responsibilities

• Lead cross-functional teams and communicate with vendors for maintenance.
• Draft and execute instrument qualification protocols and procedures.

Skills

Quality GMP environment experience

Troubleshooting equipment

Technical writing

Team-oriented mindset

Microsoft Office proficiency

Tools

Empower

SAP

Meridian

Kneat system

PCR machines

DNA sequencing

ddPCR equipment

Job description

HIRING METHOD - 1 Year Long Contract with extension OR possible permanent conversion

AMENITIES - 10 Days of PTO / 6 Sick Days / Paid Holidays

RATE: $36.75/hr to $45.97/hr.

Exact compensation may vary based on several factors, including skills, experience, and education.

Healthcare benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, financial protection benefits, as well as HSA, FSA, and DCFSA account options. 401k retirement account access is offered starting on the 90th day with employer matching after one year of service. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

JOB DESCRIPTION

- Minimum 4 years of experience working within a Quality GMP environment with troubleshooting exposure of equipment

- USP, EP and Compendial standards

- Minimum 4 years of experience with qualification of GMP instrumentation

- Strong experience utilizing Microsoft Office

- Go-getter personality with team-oriented mindset

NICE TO HAVE SKILLS & EXPERIENCE

- Empower, SAP, Meridian, Kneat system experience

- Background with cell counters, flow cytometers, plate readers, PCR machines, DNA sequencing, ddPCR equipment

- Experience with technical writing

- Creating protocols and procedures, validation documentation

- Experience working with 21 CFR Part 11 assessment or ANNEX 11 assessment

One of our large pharmaceutical clients is looking to hire a Qualification Analyst for the Equipment Lifecycle Management team within the Quality department. This individual will be responsible for following Quality Control procedures on the installation, qualification, and maintenance of GMP analytical instruments for the Clinical Release and Stability lab in Malvern PA. Responsibilities will include:

• Leading and participating in cross-functional teams.
• Communicating with vendors to coordinate maintenance and troubleshooting activities.
• Must follow Good Documentation practices.
• Draft and execute instrument qualification protocols, site operating procedures, and other technical documents with minimal guidance once trained on internal processes.
• Draft protocols, supporting documents, and procedures for new instruments and equipment.
• Write and execute QC analytical equipment qualifications.
• Connect with QA to follow up on investigations to understand the root cause.
• Overall Equipment lifecycle management.

SENIORITY LEVEL

Associate

EMPLOYMENT TYPE

Full-time

JOB FUNCTION

Project Management, Engineering, and Science

INDUSTRIES

Pharmaceutical Manufacturing and Biotechnology Research