Associate Quality Account Manager

PCI Pharma Services; Philadelphia (Philadelphia County); Vor Ort; USD 65.000 - 85.000; Vollzeit

Zusammenfassung

PCI Pharma Services is seeking an Associate Quality Account Manager I to coordinate quality activities for designated customer teams in Philadelphia, PA. The role supports batch record reviews, quality documentation, and customer communications to maintain cGMP compliance and deliverables.

Responsibilities include assisting with deviation investigations, KPI reporting, and training junior staff, while ensuring adherence to PCI policies and standards in a fast-paced pharmaceutical packaging

Qualifikationen

• High school education and at least five (5) years of pharmaceutical packaging experience preferred.
• Proficiency with MS Office and technical software; ability to work with data tables and graphs.
• Strong organizational, time-management and multitasking skills to meet commitments and deadlines.
• Excellent oral and written communication; ability to interact with management, customers, suppliers and agencies at all levels.
• Lean Six Sigma or process-improvement training is a plus.
• Ability to interpret scientific tables, charts and graphs; strong numerical acumen.

Aufgaben

• Coordinate quality activities for a designated Customer Focused Team to meet goals within time and budget.
• Assist with batch record reviews of completed orders and orders in process for cGMP compliance.
• Create batch records to support the production schedule and act as primary QA contact for assigned customers.
• Liaise with customers regarding quality documentation; identify and resolve document-related issues.
• Attend or facilitate conference calls and customer meetings to share or gather quality metrics.
• Populate quality metrics and KPIs for team performance; support investigations of deviations.

Kenntnisse

Organizational skills

Time management

Multi-tasking

MS Office

Technical software

Interpersonal communication

Data interpretation

Lean Six Sigma

Ausbildung

High school diploma

College degree in a scientific discipline

Jobbeschreibung

Associate Quality Account Manager I

Location: Philadelphia, PA, USA

Time Type: Full time

Job Description

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

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

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:

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.

#LI-KH1

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

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.