QC Analyst-Shift

PSC Biotech Corporation; Cork; On-site; EUR 45,000 - 60,000; Full time

Job summary

PSC Biotech Corporation in Cork, Ireland is seeking a QC Analyst to join their QC In Process Control team. This exciting role offers exposure across Drug Substance and Drug Product manufacturing in a highly compliant GMP environment.

The ideal candidate will have a BSc or MSc in a scientific discipline, with extensive cGMP laboratory experience. You’ll be responsible for delivering high-quality test results and supporting a culture of continuous improvement.

Qualifications

• Experience in QC raw data review and trend analysis.
• Preparation of protocols and reports for regulatory agencies.
• Interaction with regulatory inspectors during audits.

Responsibilities

• Support internal customers with compliant test results.
• Prepare QC Standard Operating Procedures (SOPs).
• Conduct laboratory investigations.

Skills

Excellent written and verbal communication skills

Strong customer focus

Self-motivated

Team-oriented

Proven adaptability and flexibility

Education

BSc in a scientific or engineering discipline with 5+ years of relevant cGMP laboratory experience

MSc with 3+ years of relevant cGMP laboratory experience

Job description

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Cork
• State/Province Cork
• Country Ireland

Job Description

About PSC Biotech

Who are we?

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 US. We serve 350 clients across more than 23 countries worldwide, providing cloud‑based software solutions for quality management, regulatory inspections, pharmaceutical contract manufacturing, and metrology services.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as a unique selling point, offering the opportunity to work with a talented cohort of like‑minded professionals in the Pharma/Biotech industry. We provide permanent contracts of employment, exposing employees to top pharmaceutical client sites in a diverse cultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech. We provide unparalleled career development through in‑house learning, development and mentorship programs, fostering continuous guidance to facilitate career progression. Our high‑performing teams exceed client expectations in quality, scalability and profitability, while staying under budget and meeting timelines.

Overview

• An exciting opportunity has arisen for a QC Analyst to join the QC In Process Control team, based in a newly 5S‑certified analytical laboratory. This role offers excellent exposure across both Drug Substance and Drug Product manufacturing in a fast‑paced, highly compliant GMP environment.
• The QC In Process team delivers comprehensive in‑process analytical and microbiological testing, supporting manufacturing operations across the site.
• Due to the critical, around‑the‑clock nature of in‑process testing, this role is part of a 4‑cycle shift team, supporting continuous manufacturing operations.
• QC In Process is a high‑performing, team‑based group where colleagues are flexible, multi‑skilled, and empowered to make decisions.
• The team operates to an exceptionally high standard of quality, compliance, and safety, with a strong focus on continuous improvement, standard work, and 5S.
• This role requires a high level of initiative, energy, and motivation, together with strong organisational skills and the ability to thrive in a dynamic manufacturing environment.

Requirements

Role Responsibilities:

Reporting to the QC Team Lead, the QC Analyst is responsible for supporting internal customers by delivering high‑quality, compliant test results in accordance with GMP standards.

Key responsibilities include, but are not limited to:

• Perform primary review of QC raw data and trend results.
• Prepare protocols, summaries, and reports, including documents submitted directly to pharmaceutical regulatory agencies.
• Draft and update QC Standard Operating Procedures (SOPs).
• Act as a technical subject‑matter expert (SME) and provide training and support to other analysts in areas of expertise.
• Evaluate analytical and microbiological results against defined acceptance criteria.
• Conduct and document laboratory investigations through to completion.
• Maintain the laboratory in a constant state of audit and inspection readiness.
• Interact directly with regulatory agency inspectors during audits and inspections.
• Interface with other functions including Manufacturing, Quality Assurance, Facilities, and external contractors as required.
• Other duties as assigned.

Desirable Skills and Attributes:

• Excellent written and verbal communication skills.
• Strong customer focus, with personal accountability for speed, quality, and accuracy of delivery.
• Self‑motivated, able to work under pressure in a fast‑paced environment.
• Team‑oriented, with active participation in team development and continuous improvement, including standard work and 5S.
• Demonstrated success in achieving goals as part of a high‑performing team in a growing organisation.
• Proven adaptability and flexibility to support an evolving operational environment.

Education and Experience:

• BSc in a scientific or engineering discipline with 5+ years of relevant cGMP laboratory experience.
• or
• MSc with 3+ years of relevant cGMP laboratory experience.