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 training and development activities as assigned.
• Perform other duties as assigned by management.

Education & Experience

Required Qualifications

• Bachelor's degree in Chemistry, Biology, Microbiology, or another related scientific discipline with relevant laboratory coursework.
• 1-2 years of laboratory experience, preferably within a GMP-regulated environment.

Preferred Qualifications

• Experience in pharmaceutical, biotechnology, or other regulated laboratory environments.
• Experience utilizing Laboratory Information Management Systems (LIMS).
• Familiarity with compendial testing requirements and pharmaceutical quality systems.

Knowledge, Skills & Abilities

• Basic knowledge of laboratory safety practices and PPE requirements.
• Basic understanding of current Good Manufacturing Practices (cGMP).
• Basic understanding of Good Documentation Practices (GDP).
• Knowledge of compendial testing requirements (USP/EP).
• Strong attention to detail and organizational skills.
• Ability to accurately document and communicate analytical results.
• Effective written and verbal communication skills.
• Ability to manage multiple priorities in a fast-paced laboratory environment.

Preferred Technical Experience

Experience with one or more of the following analytical techniques and laboratory functions is preferred:

• FTIR (Fourier Transform Infrared Spectroscopy)
• Dissolution Testing
• UV-Visible Spectroscopy (UV-VIS)
• Karl Fischer Analysis
• pH Testing
• Wet Chemistry Techniques
• Reagent Preparation
• Volumetric Solution Preparation

Physical Demands

• Ability to work in a laboratory environment for extended periods.
• Frequent standing, walking, reaching, and performing laboratory activities.
• Ability to handle laboratory equipment, chemicals, and testing materials safely.
• Ability to lift and move materials and supplies as required.

Work Environment

• Quality Control laboratory environment supporting pharmaceutical manufacturing operations.
• Exposure to laboratory chemicals and materials in accordance with established safety procedures.
• Required use of personal protective equipment (PPE), including safety glasses, gloves, lab coats, and other protective equipment as necessary.
• Second-shift schedule supporting ongoing laboratory and manufacturing operations.