Associate Quality Account Manager I

PCI Pharma Services•Philadelphia, PA

About The Position

The Associate Quality Account Manager I assists with coordinating quality activities for a designated Customer Focused Team to help accomplish team goals and objectives within prescribed time frames and budgets. The role supports project success and long-term quality customer management. It serves as the primary Quality Assurance contact for assigned customer accounts and as a company liaison with customers on quality control documentation. The position creates, updates, and peer reviews Master Packaging Instructions, forms, and material specifications to ensure they meet internal and customer requirements, and helps obtain approvals. It also supports batch record creation and review, quality issue tracking and resolution, quality metrics, deviation investigations, and supplier non-conformance reporting. The role collaborates with internal departments, customers, suppliers, and other parties, and may assist with training and mentoring new Quality Coordinators. The employee must follow PCI and cGMP policies, procedures, rules, and regulations. Attendance is an essential function. The work environment typically has a moderate noise level. The employee must occasionally lift or move up to 10 pounds and requires close, distance, and color vision, with reasonable accommodations available as applicable.

Requirements

High school education and at least five years of pharmaceutical packaging experience.
Excellent organizational, time-management, and multitasking skills to meet commitments and deadlines.
Basic proficiency with personal computers, business software such as MS Office, and technical software.
Ability to create, use, and interpret scientific tables, charts, and graphs.
Highly developed oral and written interpersonal communication skills to communicate effectively with company management, customers, suppliers, and agencies at all levels.
Ability to apply fractions, percentages, ratios, and proportions to practical situations.
Ability to perform the essential duties, with or without reasonable accommodation.
Ability to occasionally lift and/or move up to 10 pounds.
Close, distance, and color vision abilities.

Nice To Haves

A college degree with a concentration in a scientific discipline.
Lean Six Sigma or process improvement training.

Responsibilities

Create, update, and peer review Master Packaging Instructions, forms, and material specifications to ensure they meet internal and customer requirements.
Obtain internal and customer approvals for Master Packaging Instructions and specifications.
Assist with reviewing completed and in-process order batch records for compliance with cGMPs and customer requirements.
Assist with creating batch records to support the production schedule.
Serve as the primary Quality Assurance contact for assigned customer accounts.
Act as a company liaison with customers concerning quality control documentation.
Help identify, communicate, track, and resolve document-related issues with other departments and customers.
Attend or facilitate conference calls and customer meetings to provide or obtain quality-related information and customer-specific metrics.
Assist with populating quality-related metrics and key performance indicators for team performance.
Assist with initiating and investigating quality deviations with responsible functional areas.
Initiate and complete supplier non-conformance reports and effectuate material control.
Assist with training, developing, and mentoring new Quality Coordinators.
Adhere to PCI and cGMP policies, procedures, rules, and regulations.
Perform other duties as assigned by the Supervisor/Manager.