QC Analyst I

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing  organization (CDMO), offering end-to-end development and manufacturing  solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.  

This enables us to offer a comprehensive range of services including Drug Discovery  Solutions, Process & Pharmaceutical Development services, Clinical Trial  Supplies, Commercial supply of APIs and Finished dosage forms. We also offer  specialized services like development and manufacture of Highly Potent APIs  and Antibody Drug Conjugation.  

Our capability as an integrated service provider  & experience with various technologies enables us to serve Innovator and  Generic companies worldwide.  

For more details, please visit : www.piramalpharmasolutions.com

Job Title

QC Analyst I

Job Description

Piramal Pharma Solutions is seeking a QC Analyst I to join our Quality Control team in Sellersville, PA. This position is responsible for performing analytical and physical testing of raw materials, finished products, stability samples, and other laboratory samples in accordance with approved procedures, compendial requirements, and current Good Manufacturing Practices (cGMP).

The QC Analyst I will support laboratory operations through accurate testing, documentation, reagent preparation, and data entry while ensuring compliance with regulatory and quality standards. This is a safety-sensitive position that requires adherence to all laboratory safety, quality, and documentation requirements.

QC Analyst I

Department: Quality Control
Location: Sellersville, PA
 

Job Overview

Piramal Pharma Solutions is seeking a QC Analyst I to join our Quality Control team in Sellersville, PA. This position is responsible for performing analytical and physical testing of raw materials, finished products, stability samples, and other laboratory samples in accordance with approved procedures, compendial requirements, and current Good Manufacturing Practices (cGMP).

The QC Analyst I will support laboratory operations through accurate testing, documentation, reagent preparation, and data entry while ensuring compliance with regulatory and quality standards. This is a safety-sensitive position that requires adherence to all laboratory safety, quality, and documentation requirements.

Key Responsibilities

Analytical Testing

• Perform chemical and physical testing of:
  • Raw materials
  • Finished products
  • Stability samples
  • In-process and other requested samples
• Execute testing in accordance with approved Standard Operating Procedures (SOPs), analytical methods, and laboratory practices.
• Generate accurate and reliable analytical results within established timelines.
• Ensure compliance with applicable USP, EP, and other compendial testing requirements.

Documentation & Data Management

• Accurately document laboratory activities and test results in accordance with Good Documentation Practices (GDP).
• Enter, review, and submit raw data and analytical results in the Laboratory Information Management System (LIMS).
• Maintain complete and accurate laboratory records to support data integrity and regulatory compliance.
• Report deviations, atypical results, and laboratory issues in accordance with site procedures.

Laboratory Support

• Prepare reagents, standards, volumetric solutions, and laboratory materials required for testing activities.
• Participate in peer review of reagent preparation and analytical documentation.
• Maintain laboratory cleanliness and organization in accordance with safety and quality requirements.
• Follow established procedures for handling laboratory chemicals, materials, and equipment.

Compliance & Safety

• Follow laboratory safety procedures and utilize appropriate personal protective equipment (PPE).
• Perform all activities in compliance with:
  • cGMP requirements
  • FDA regulations, including 21 CFR requirements
  • Site quality systems and procedures
• Support laboratory investigations, audits, and inspections as required.
• Promote a culture of safety, compliance, and continuous improvement.

Additional Responsibilities

• Assist with laboratory projects and continuous improvement initiatives.
• Support t