Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
We are looking for a Quality Technician (Clinical Business Unit City North) to join our office in Stamullen, Ireland.
Summary Of Role
To perform the Quality Control function and assist in QA functions required to support PCI Clinical Storage and Distribution Operations.
The Incoming Quality Control Inspector is responsible for verifying incoming materials received from suppliers are in compliance with company drawings, specifications, and requirements. The verification process includes, but is not limited to: current revision, total quantity, material type, physical dimensions, aesthetic appearance, etc. and will involve the use of inspection equipment. The position will also be responsible for interacting with internal (other PCI sites and internal departments) and external customers, to determine the cause and disposition of non-conforming material.
Key Responsibilities
* Conduct QC inspection processes for:
* Incoming materials
* Works order checks (IPCs)
* Master label proofs
* Label checks
* Finished product
* Just in time (JIT)
* To release PCI manufactured product
* Co-ordinate and complete temperature reviews
* To monitor and update the QC status of materials at PCI
* General; scanning, archiving and filing of quality records
* Assist in the review of completed batch documents
* Assist with the investigation of quality related incidents
* Assist with core QMS activities where required
* Assist with general administration duties within the Quality Assurance department
Outcomes Of Role
* Operations satisfaction with service (no delays to Operations due to QC).
* Fully traceable QC status for all materials at PCI.
Specific Qualifications
* Leaving Cert and previous experience within cGMP regulated environment.
* Formal qualification in a scientific discipline an advantage.
Essential Knowledge / Skills & Experience
* High level of understanding of the principles and application of GMP (or equivalent).
* Organisational skills.
* Show high attention to detail.
* IT skills (minimum of Excel and Word).
Desirable
* Previous role as a QC inspector or in Operations in a highly regulated manufacturing or warehouse operations process.
* Planning and Organising
* Customer service
* Flexibility
* Teamwork and collaboration
* Good communication skills
* Good written communication skills
* Judgement and decision making
* Self confidence
* Verbal communication
* Trustworthiness
* Conscientiousness
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future.
Equal Employment Opportunity (EEO) Statement
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
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