QC NPI Analyst, Loughrea

Company Overview PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the U.S. We serve 350 clients in more than 23 countries worldwide, providing cloud‑based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services.

Opportunity This role is part of the Quality Control New Product Introduction team. You will support and drive the client’s pharmaceutical vision to provide high‑quality, competitively priced products and exceptional services. You will report to the QC Manager.

Responsibilities

Learn and apply analytical techniques, including HPLC, GC, IR, UV, dissolution, and physical testing.

Carry out analytical testing on raw materials, APIs, and excipients using appropriate GMP, SOPs, and regulatory procedures, ensuring minimal human error.

Plan, prioritise, and execute analytical activities in alignment with Team Leader, Purchasing, R&D, and Product Launch to meet project timelines.

Adapt testing priorities in response to evolving R&D, product launch, and purchasing requirements, in agreement with the QC Manager.

Prepare experimental protocols and support vendor approval.

Perform analytical method transfers for raw materials and packing materials, including protocol and report preparation.

Perform analytical method validation and verification for raw materials and packing materials.

Characterise APIs and reference products for proposed veterinary or raw material products.

Approve raw materials and issue associated documents and labels.

Send, follow up, and file external testing results, circulating them to relevant stakeholders.

Respond to queries from third parties or regulatory authorities within agreed timelines.

Write technical reports.

Ensure timely availability of reagents, chemicals, test methods, and columns, liaising with external suppliers to avoid testing delays.

Maintain logs, experiment registers, and laboratory notebooks contemporaneously.

Review analytical raw data for raw material testing and method validation/verification.

Generate data to support existing protocol changes for DMF/supplier technical updates.

Calibrate and maintain laboratory equipment per calibration procedures.

Suggest improvements to the NPI process for lean management and continuous improvement.

Communicate with R&D, QC, Product Launch, Quality Assurance, Regulatory Affairs, and Purchasing, following up on queries promptly.

File, report, and organise raw data generated during analysis.

Notify the QC supervisor of discrepancies, deviations, or non‑conformances in testing or work practices, complying with cGMP and data integrity principles.

Investigate OOS/OOT laboratory incidents and perform root cause analysis.

Represent the company during internal or external audits, including customer or regulatory audits.

Maintain the QC laboratory to GLP standards and adhere to lab rota tasks.

Maintain good housekeeping and hygiene within the laboratory, following safety measures at all times.

Perform any other duties assigned by the Team Leader or Manager.

Competencies

Experience in a GMP laboratory, R&D (formulation), or raw material testing.

Proficiency with Microsoft Office.

Excellent communication and interpersonal skills; collaborative mindset.

Ability to work independently and as part of a team in a fast‑paced environment.

Strong written communication skills.

Capacity to build relationships and collaborate with others.

High ethical standards and appropriate escalation of issues.

Flexibility and willingness to learn technical skills.

Methodical, systematic, and structured approach to organising work.

Positive and proactive attitude, energized by responsibility.

Qualifications

Bachelor’s degree in a chemistry‑based discipline.

Experience in analytical method transfer, technical transfer, analytical method validation/verification, and raw material testing.

3+ years of experience in an R&D or QC analyst role.

Experience working in a cGLP/cGMP environment with knowledge of EU GMP and US FDA guidelines.

Physical Demands

Take reasonable care of personal safety, health, and welfare at work.

Cooperate with clients or representatives to comply with health and safety statutory provisions.

Adhere to safety regulations and use PPE correctly in the lab.

Report plant, equipment, or procedural defects swiftly to a supervisor or safety representative.

Keep the work area safe, clean, and tidy.

Do not misuse or interfere with protective clothing, equipment, or other provided resources.

Work Environment Laboratory‑based duties predominating, in a controlled laboratory setting.

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