Associate Quality Account Manager II

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. Position Title: Associate Quality Account Manager ll Location: Philadelphia, PA Shift: 1st Shift Summary of Objective: Responsible for leading efforts in plannings, directing, and coordinating customer focus team. Quality activities to ensure that the quality of PCI’s products are in compliance with customer requirements as well as state and federal regulations. Lead and play an integral part in individual project success and provide PCI a competitive advantage in long-term customer 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. Accountable for overall management and reviewing, planning, and administering of resource allocation and workload planning. Responsible for direct supervision and personnel development including training and mentoring of direct reports. Responsible for training, developing, and mentoring new Quality Coordinators Customer contact for quality activities and management of customer expectations Primary escalation contacts for quality related issues Attend conference calls and customer meetings to provide quality related information Generate and present quality related metrics and key performance indicators for team’s performance to internal BU members and PCI Management Reviews and interprets customer standards, procedures, and specifications for dissemination relative to batch records, forms, and material specifications 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 Instructions and specifications Assist with reviewing batch records, forms, and specifications to ensure that the documents meet internal and customer requirements for standards, procedures and requirements. Assist with performing batch record reviews of completed orders and orders in process to ensure compliance with cGMP’s and customer requirements Assist as company liaison with customers concerning quality control documentation Help identify, communicate, track, and resolve document related issues with other departments and customers Assist with addressing quality events with Production and QC teams Timely provision of reports and requested information to customers Functions as the customer point of contact for any comments or questions pertaining to defect events and investigations Investigate deviations and document investigation in formal report Enter, monitor, track, extend and close investigations and CAPA information in Quality Management System Meet with management to address issues or concerns with the deviations Collaborate with the appropriate Project Manager and Business Unit Manage to coordinate and facilitate the customer Quarterly Business Review’s Generate and present quality related metrics and key performance indicators for team’s performance Review and approve internal and customer-based specifications for packaging components and processes Manage customer visits May include travel to meet with customers on project and attend Business reviews Attendance to work is an essential function of this job Adherence to PCI and cGMP policies, procedures, rules and regulation Other duties as assigned by Supervisor/Manager SUPERVISORY RESPONSIBILITIES: Supervises up to 5 associates within the customer Focused Team. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; staffing, planning, assigning, and directing work, appraising performance, rewarding and disciplining employees, addressing complaints and resolving problems. 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 Required: Bachelor’s degree (B. A) from a four-year college or university; or three to five years related experience and/or training; or equivalent combination of education and experience. A history of project accomplishment and leadership excellence strongly desired Must have excellent computer skills including Microsoft Word, excel, PowerPoint, Outlook, and Project, and a working knowledge of GMPs. Language Skills: Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to management, and customers. Must have strong interpersonal and excellent communication skills Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule forms #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.