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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.

Summary of Objective:

Responsible for leading efforts in plannings, directing, and coordinating customer focus team Quality activities to ensure that the quality of PCI’s products is in compliance with customer requirements as well as state and federal regulations. Lead and play an integral part in individual project success and provide PCI a competitive advantage in long-term customer management.

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.

+ Accountable for overall management and reviewing, planning, and administering of resource allocation and workload planning.

+ Responsible for direct supervision and personnel development including training and mentoring of direct reports.

+ Responsible for training, developing, and mentoring new Quality Coordinators

+ Customer contact for quality activities and management of customer expectations

+ Primary escalation contacts for quality related issues

+ Attend conference calls and customer meetings to provide quality related information

+ Generate and present quality related metrics and key performance indicators for team’s performance to internal BU members and PCI Management

+ Reviews and interprets customer standards, procedures, and specifications for dissemination relative to batch records, forms, and material specifications

+ Creates, updates and peer reviews Master Packaging Instructions, forms, and material specifications to ensure that the documents meet internal and customer requirements, as well as obtaining internal and customer approvals of Master Instructions and specifications

+ Assist with reviewing batch records, forms, and specifications to ensure that the documents meet internal and customer requirements for standards, procedures and requirements.

+ Assist with performing batch record reviews of completed orders and orders in process to ensure

+ compliance with cGMP’s and customer requirements

+ Assist as company liaison with customers concerning quality control documentation

+ Help identify, communicate, track, and resolve document related issues with other departments and customers

+ Assist with addressing quality events with Production and QC teams

+ Timely provision of reports and requested information to customers

+ Functions as the customer point of contact for any comments or questions pertaining to defect events and investigations

+ Investigate deviations and document investigation in formal report

+ Enter, monitor, track, extend and close investigations and CAPA information in Quality Management System

+ Meet with management to address issues or concerns with the deviations

+ Collaborate with the appropriate Project Manager and Business Unit Manage to coordinate and facilitate the customer Quarterly Business Review’s

+ Generate and present quality related metrics and key performance indicators for team’s performance

+ Review and approve internal and customer-based specifications for packaging components and processes

+ Manage customer visits

+ May include travel to meet with customers on project and attend Business reviews

+ Attendance to work is an essential function of this job

+ Adherence to PCI and cGMP policies, procedures, rules and regulation

+ Other duties as assigned by Supervisor/Manager

Qualifications:

Required:

+ Associate degree in a related field and/or 1-3 years related experience and/or training.

+ Basic Mathematical Skills

+ Intermediate Computer Skills: Ability to perform more complex computer tasks and have knowledge of various computer programs.

+ Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.

+ High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.

Preferred:

+ Ability to identify and resolve problems in a timely manner.

+ Ability to display a willingness to make decisions.

+ Ability to display excellent time management skills.

+ Ability to follow instructions and respond to management direction.

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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