Associate Quality Account Manager II

PCI Pharma Services•Philadelphia, PA

13d•Onsite

About The Position

Responsible for leading efforts in planning, directing, and coordinating customer focus team quality activities to ensure that the quality of PCI’s products are 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.

Requirements

Bachelor’s degree (B. A) from a four-year college or university; or three to five years related experience and/or training; or equivalent combination of education and experience.
A history of project accomplishment and leadership excellence strongly desired
Must have excellent computer skills including Microsoft Word, excel, PowerPoint, Outlook, and Project, and a working knowledge of GMPs.
Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents.
Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
Ability to effectively present information to management, and customers.
Must have strong interpersonal and excellent communication skills
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule forms

Responsibilities

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
Supervises up to 5 associates within the customer Focused Team.
Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; staffing, planning, assigning, and directing work, appraising performance, rewarding and disciplining employees, addressing complaints and resolving problems.