Associate Quality Account Manager I

PCI PHW Packaging Coordinators Inc.; Philadelphia (Philadelphia County); Vor Ort; USD 60.000 - 80.000; Vollzeit

Zusammenfassung

PCI Pharma Services is seeking an Associate Quality Account Manager I in Philadelphia to coordinate quality activities for a designated customer-focused team. You will help ensure goals are met within timelines and budgets while supporting batch records, deviations, and customer QA documentation.

The role requires strong attention to detail, communication skills, and experience with GMP packaging operations. A collaborative, quality-driven mindset is essential to drive continuous improvement.

Qualifikationen

• Experience coordinating quality activities in a GMP/pharma environment.
• Ability to review and ensure compliance with cGMP and customer requirements.
• Strong documentation, data tracking and metrics skills.
• Excellent communication with customers and internal teams.

Aufgaben

• Create, update and peer review Master Packaging Instructions and specs to meet internal and customer requirements.
• Perform batch record reviews and support production scheduling.
• Serve as Primary QA contact for assigned customer accounts and liaise with customers on QA docs.
• Populate quality metrics and KPIs for team performance.
• Initiate investigations of deviations and supplier non-conformances.
• Train, develop and mentor new Quality Coordinators.

Kenntnisse

Lean Six Sigma

MS Office

Communication skills

Multitasking

Ausbildung

High School Diploma

Bachelor's degree in a scientific discipline preferred

Tools

MS Office Suite

Quality documentation tools

Jobbeschreibung

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 within 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. 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.

Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.