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 QA Warehouse Specialist to join our team in Dundalk.
Sample, approve, and release incoming goods, packaging materials, and products (where required) for use in production
Request and review Certificates of Analysis (CoA) / Certificates of Conformance (CoC) for incoming goods, packaging materials, and products
Review and file acetates for use during sampling activities
Identify training needs and conduct staff training as required
Maintain sampling documentation and archive retain samples
Manage the Supplier/Customer Defect (SCD) system, including issuance of SCD numbers, coordination with customers and suppliers, and closure of SCDs
Liaise with customers and suppliers on artwork-related queries and manage artwork approvals
Review and approve Master Packaging Material Specifications
Ensure high standards of housekeeping; conduct housekeeping audits and prepare reports
Raise, investigate, and close deviations and Corrective and Preventive Actions (CAPA) as required
Ensure all activities are conducted in compliance with current Good Manufacturing Practice (cGMP) requirements
Assist in validation studies as required
Ensure safe work practices are followed at all times, report safety issues immediately to the Safety Officer, and attend Health and Safety meetings
Perform other duties as required from time to time in line with the overall goals of the company
Relevant experience may be considered in lieu of formal educational requirements
Proven track record of delivering results
Ability to work toward clearly defined goals, communicate progress effectively, and meet predefined targets
Bachelor’s or Associate Degree, or Diploma/Certificate in Quality, Pharmaceutical Science, or a related discipline
One to two years of experience working in Quality / QA
Ability to manage multiple tasks and prioritize effectively based on business needs
Strong problem-solving and troubleshooting skills, with a dynamic and proactive approach
Self-motivated with a results-driven mindset
Flexibility to work across different shifts as required in line with business needs
Adaptable and able to work collaboratively within cross-functional teams
Proficient in Microsoft Office applications (including Excel, PowerPoint, Word, etc.)
Willingness to travel between sites based on company requirements
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, Equity and Inclusion 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.
