Customer Quality Lead Job Dundalk area,Maryland USA,Quality Assurance

Dundalk, Co. Louth, IRL
Full time
JR

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.

Job Description

Role Overview

Customer Quality Lead (CPL) Plans, directs, and coordinates Quality Operational activities for dedicated customers to ensure that goals and objectives of the team (PCI QA Ops and Customer) are accomplished within prescribed time frames and in budget. Maintains a positive working relationship with internal and external customers. Customer Point of Contact (POC), attending the weekly/monthly meetings, provides QA Operational QKI's (RFT among others) and works with QA Technician ensuring batches are reviewed and ready for customer as per agreed timelines.

Primary

Responsibilities

Assist with performing 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 batch documentation.

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

Attend conference calls and customer meetings; provide complaint and quality related information.

Assist with generating and presenting quality related metrics and key performance indicators for team's performance.

Assist with the investigation of Quality deviations and the drafting of investigation reports associated with such deviations.

Disposition of Events and NONC's

Assist with addressing and documenting quality events with Production and Quality teams.

Assist with training, developing, and mentoring new QA Technician.

Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.

Attendance to work is an essential function of this position.

Performs other duties as assigned by Manager/Supervisor.

Develop, update, and implement procedural changes throughout QA Operations

Standardize documentation to ensure PCI's Standard for Quality is achieved throughout our customer base.

Coach, train, mentor and develop PCI's employees to ensure Quality Standards are met and maintained.

Assist with In-Process / Finished Goods Inspections, Annual Retain Inspections, Customer Complaint Samples or Rework as needed to support the various groups throughout PCI.

Compile, update and analyse customer / internal data and metrics to identify potential trends and areas for opportunities. Utilize the Microsoft Office Suite in detail to present data / facts in a professional fashion.

Maintain positive external and internal customer relationships with face-to-face, email and voice communication. Provide the appropriate feedback within 24 hours of notification.

Assist with Supplier Investigations as needed.

Assess and provide detailed reports / summaries on the impact of process changes to PCI management.

Secondary Responsibilities

Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company

Requirements

Bachelor's degree in Pharmacy, Microbiology, Chemistry, Biology or related fields
Minimum 1 year of pharmaceutical industry experience
Ability to work with minimal supervision
Proficiency with MS Office Suite programs
Excellent attention to detail
Superior communication skills
Skilled at driving and providing training to other staff members
Strong analytical and problem-solving skills.

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…