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Job Title: Associate Quality Account Manager I

Department/Group: Quality

Location: Philadelphia

Summary of Objective:

Assists with coordinating quality activities of a designated Customer Focused Team to ensure that goals and objectives of the team are accomplished withing prescribed time frames and in budget. Helps drive project

success to provide PCI a competitive advantage in long-term quality customers management

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform

each essential duty satisfactorily.

The essential duties and responsibilities include the following but other duties

may be assigned.

• 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 Packaging Instructions and specifications.
• Assist with performing batch record reviews of completed orders and orders in process to ensure compliance with cGMP’s and customer requirements.
• Assist with creating batch records to support the production schedule
• Primary Quality Assurance contact for assigned customer accounts
• Assist as 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’s performance
• Assist with initiating and investigating quality deviations with the responsible functional areas
• Initiating and completing supplier non-conformance reports and effectuates material control
• Assist with training, developing, and mentoring new Quality Coordinators
• Adherence to PCI and cGMP policies, procedures, rules and regulations
• Attendance to work is an essential function of this job
• Other duties as assigned by Supervisor/Manager
• No Supervisory responsibilities

Special Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed

below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• Must be physically capable to perform the above duties with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions
• The employee must occasionally lift and/or move up to 10 pounds.
• Specific vision abilities required by this job include close vision, distance vision, and color vision

Work Environment:

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be

made to enable individuals with disabilities to perform the essential functions.

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essentials functions
• The noise level in the work environment is usually moderate

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions Required: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirement listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

Preferred:

• High school education and at least five (5) years of pharmaceutical packaging experience. A college degree with a concentration in a scientific discipline is preferred.
• Possesses excellent organizational, time management and multi-tasking skills in order to meet commitments and deadlines.
• The candidate must be able to demonstrate basic proficiency with personal computers, business software (e,g., MS Office) and technical software
• Ability to create, use and interpret scientific tables, charts, and graphs.
• Any Lean Six Sigma or process improvement training is a plus
• Highly developed oral and written interpersonal communication skills to effectively communicate with
• company management, customers, suppliers, and agencies at all levels
• Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.

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Equal 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.