Quality Specialist

4 days ago


California, United States PSC Biotech Corporation Full time
  • Industry Pharma/Biotech/Clinical Research
  • Work Experience 1-3 years
  • City Carlow
  • State/Province Carlow
  • Country Ireland
Job Description

About PSC Biotech

Who we are?
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, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points, which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/Biotech Industry. We offer a permanent contract of employment giving exposure to working in top pharmaceutical client sites in a diverse cultural work setting.

Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech. We provide unparalleled empowering career development through Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client’s expectations regarding the quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Role Description:
The Quality Specialist will perform an integral role in the Engineering team. They will work within a small team that will be mainly responsible for compliance aspects within the Engineering CoE team. This will include but is not limited to the completion of investigations, generation and management of change controls, and supporting the IFM Compliance and EHS Engineer as required.

Requirements

Role Functions:

  • Support Engineering activities through documentation generation, equipment and process investigations associated with GMP activities and completion of quality notifications.
  • Be a document system expert; this will include document review, approval, and document system workflow expedition. Format, write, deliver, and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOPs, SWIs, training documents, and change controls.
  • Raise CAPAs and conduct investigations. Raise and investigate quality notifications using standard tools and methods to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.
  • Required to comply with client Global Policies, Procedures and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
  • Support and lead Internal Quality audits of the Engineering Department.
  • Assist in the management and/or assignment of Engineering training if required.
  • Work collaboratively to drive a safe and compliant culture in Carlow.
  • May be required to perform other duties as assigned.

Experience, Knowledge & Skills:

General:

  • Demonstrating energy and enthusiasm, the Quality Specialist will be a role model for operational excellence, and will contribute to the department's overall capability to thrive and grow.
  • Proven track record in delivering results in a world-class supply organization.
  • A strong career history in pharma (ideally working in a clean utilities and/or compliance environment) and familiarity with a highly regulated environment.
  • Innovative thinker, with excellent decision-making and problem-solving skills.
  • Experience of working in a cross-functional environment.
  • Knowledge of and experience in applying Six Sigma and Lean methodologies.
  • Positive, flexible action-oriented attitude.

Technical:

  • Experience in Compliance systems such as IPI, SAP etc. a distinct advantage.
  • Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
  • Proficiency in Microsoft Office and job-related computer applications required.
  • Experience working within an Engineering environment in a regulated industry a distinct advantage.

People:

  • The desire to continuously learn, improve and develop.
  • Excellent communication, presentation, and interpersonal skills, to interface effectively with levels of colleagues and with external customers in a team-oriented manner.
  • Excellent training, facilitation, and assessment skills.
  • Demonstrable analytical and systematic problem-solving skills.
  • Flexible approach.
  • Effective time management and multi-tasking skills.
  • Proven organizational skills.
  • Excellent attention to detail.
  • Goal/results-oriented.

Qualifications & Education:

  • Degree qualification or equivalent Min Level 7 (Science, Engineering, Technical).
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