Associate Quality Account Manager I

PCI Pharma Services•Philadelphia, PA

6d•Onsite

About The Position

The Associate Quality Account Manager I assists in coordinating quality activities for a designated Customer Focused Team, helping the team accomplish its goals and objectives within prescribed time frames and budget. The role supports project success and long-term quality customer management. It serves as the primary Quality Assurance contact for assigned customer accounts and helps coordinate quality documentation and related issues with customers and internal departments. The position creates, updates, and peer reviews Master Packaging Instructions, forms, and material specifications, and obtains required internal and customer approvals. It also supports batch record preparation and review, quality metrics, deviation investigations, supplier non-conformance reporting, and material control. The employee follows PCI and cGMP policies and procedures, attends work as an essential function, and may perform other duties assigned by a supervisor or manager. The position has no supervisory responsibilities. The role is located in Philadelphia. The work environment typically has a moderate noise level. Physical demands include occasionally lifting and/or moving up to 10 pounds and using close, distance, and color vision; duties must be performed with or without reasonable accommodation.

Requirements

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 concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to perform the essential duties satisfactorily, with or without reasonable accommodation.

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.
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 regarding quality control documentation; help identify, communicate, track, and resolve document-related issues with customers and other departments.
Attend or facilitate conference calls and customer meetings to provide or obtain quality-related information and customer-specific metrics.
Assist with populating quality 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.
Attend work as an essential function and perform other duties as assigned by a supervisor or manager.