Customer Quality Lead, Stamullin

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

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. Serves as Customer Point of Contact (POC), attends 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 analyze 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.

Equal Employment Opportunity 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, affectionate 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.

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