QC Analyst I

Piramal Pharma Ltd•Sellersville, PA

11d•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

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.
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.

Responsibilities

Perform chemical and physical testing of raw materials, finished products, stability samples, and 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.
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.
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.
Follow laboratory safety procedures and utilize appropriate personal protective equipment (PPE).
Perform all activities in compliance with cGMP requirements, FDA regulations (including 21 CFR), and site quality systems and procedures.
Support laboratory investigations, audits, and inspections as required.
Promote a culture of safety, compliance, and continuous improvement.
Assist with laboratory projects and continuous improvement initiatives.
Support training and development activities as assigned.
Perform other duties as assigned by management.