Clinical Associate Project Manager

Pci Pharma Services • Bridgewater, MA

387d

About The Position

The Clinical Associate Project Manager plays a crucial role in coordinating quality activities within a designated Customer Focused Team at PCI Pharma Services. This position is responsible for ensuring that project goals and objectives are met within specified time frames and budgets, ultimately contributing to the company's competitive advantage in quality customer management. The role involves managing documentation, compliance with regulations, and facilitating communication between various stakeholders to ensure project success.

Requirements

• Associate's Degree in a related field and/or 1-3 years related experience and/or training.
• Intermediate computer skills with the ability to perform complex tasks and knowledge of various computer programs.
• Full professional proficiency in speaking, reading, and writing relevant to professional needs.
• High reasoning ability to solve practical problems and interpret various instructions.

Nice To Haves

• Demonstrated attention to detail.
• Ability to work independently and as part of a team.
• Professional demeanor and effective presentation skills.

Responsibilities

• Create, route internally, and obtain customer approval of batch records and packaging material and distribution specs.
• Perform record reviews of completed orders and orders in process to ensure compliance with cGMP's and customer requirements.
• Participate in conference calls and customer meetings for assigned projects as needed.
• Act as a company liaison with customers concerning quality control documentation.
• Identify, communicate, track, and resolve document-related issues with other departments and customers.
• Generate and present quality-related metrics and key performance indicators for the team's performance.
• Address and document quality events with Production and Quality teams.
• Train, develop, and mentor new Quality Specialists and ACQM's.
• Participate in audits as needed.
• Develop, write, revise, and review work practices and forms in accordance with PCI and GMP requirements.
• Ensure CAPA's effectiveness and timeliness.
• Write, coordinate, and maintain quality-related investigations, including exception events and customer-specific investigations.
• Write and/or review Exception Reports for packaging, receiving, and distribution.

Benefits

• Equal Employment Opportunity (EEO) commitment
• Diversity, Equity, and Inclusion (DEI) initiatives

What This Job Offers

• Job Type: Full-time
• Industry: Administrative and Support Services
• Education Level: Associate degree