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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.

The Manager, Visual Inspection, Packaging, and Labeling reports directly to the Director of Operations. This role is responsible for overseeing a team of inspection and packaging technicians, ensuring timely product inspection, documentation, bulk packing, labeling, and shipping of sterile clinical and commercial products in compliance with cGMP regulations and in-house SOPs.

**Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

+ Monitor the Visual inspection operator qualification program and ensure that the qualification process meets current regulatory expectations

+ Provides technical support and leadership to all Visual Inspection and Packaging areas across three manufacturing sites

+ Directly monitor all inspection, labeling, and packaging procedures and ensure all finished products are properly identified and labeled.

+ Ensures all documentation for client related operations are complete and verified in the batch records, protocols, room logbooks, and equipment logbook each day.

+ Investigates and resolves deviations associated with Visual Inspection and Packaging process

+ Executes designated schedules to meet customer and marketing demands

+ Creates and maintains metrics relating to defect rate, inspection throughput, and on time and right first-time delivery

+ Ensures visual inspection process and operator qualification process maintain compliance to applicable regulatory markets

+ As needed, participates in audits by customers and regulatory bodies as the Visual Inspection SME

+ Increase efficiency and productivity by promoting systems, training, and proper record keeping

+ Provide assistance with deviant investigations and provide input to root cause analysis and resolution.

+ Development of Visual Inspection team through individual reviews, goals and objective

COMMUNICATIONS & CONTACTS

+ Primarily interacts with staff in the following departments at all levels: Operations, Quality, Validations, Facilities.

+ Will also interact with external vendors

MANAGERIAL & SUPERVISORY RESPONSIBILITIES

+ Manage up to 15 Direct / Indirect Reports

EDUCATION, PROFESSIONAL SKILLS, & EXPERIENCE

+ BS degree in related field with 4+ years related experience along with 2+ years of supervisory experience

+ SME in Visual Inspection of large and small volume parenteral, both Liquid and Lyophilized presentations

+ Experience in aseptic processing of commercial or clinical parenteral required

+ Experience with inspection and manufacturing equipment/processes that comply with regulatory requirements

+ Experienced with GMPs, SOPs and working within an FDA / EU regulated environment

+ Excellent technical writing, verbal communication, and presentation skills

+ Work across multiple departments to achieve goals and objectives

+ Proficiency in Microsoft Office including Word, Excel and PowerPoint

+ Ability to coach, train and mentor employees

\#LI-LL1

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

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._

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled