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.

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 customer management. Updates Batch Record Documentation and Material Specifications to ensure compliance standards are met and maintained. Facilitates customer questions for Batch Record review and Documentation Updates. Maintains a positive working relationship with internal and external customers.

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.

• Primary reviewer for master batch records, forms, and specifications to ensure that the documents meet internal and customer requirements for standards, procedures, and requirements.

• Assist with creating and updating batch records, forms, and material specifications as well as organizing internal and customer approval of batch records and specifications.

• Assist with performing record reviews of completed orders and in-process orders 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.

• Performs finished product batch release of approved production lots.

• Attend conference calls and customer meetings; provide complaint and quality related information.

• Assist in the preparation of annual product review data.

• Assist with generating and presenting quality related metrics and key performance indicators for team's performance.

• Assist with the investigation of Quality deviations and the drafting of investigation reports associated with such deviations.

• Assist with addressing and documenting quality events with Production and Quality teams.

• Assist with training, developing, and mentoring new Quality Coordinators.

• This position may require overtime and/or weekend work.

• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules.

• Attendance to work is an essential function of this position.

• Performs other duties as assigned by Manager/Supervisor.

• Develop, update and implement procedural changes throughout the organization.

• Standardize documentation to ensure PCI's Standard for Quality is achieved throughout our customer base.

• Coach, train, mentor and develop PCI's employees to ensure Quality Standards are met and maintained.

• Schedule, host and lead meetings to develop, implement and / or update Batch Records, Material Specifications, Forms, Work Practices and Standard Operating Procedures.

• Assist with In-Process / Finished Goods Inspections, Annual Retain Inspections, Customer Complaint Samples or Rework as needed to support the various groups throughout PCI.

• Compile, update and analyze customer / internal data and metrics to identify potential trends and areas for opportunities.

• Utilize the Microsoft Office Suite in detail to present data/facts in a professional fashion.

• Assist and Support the RIT Investigation process through on-line interactions with the Operations staff.

• Provide a summary of the findings/investigation to the appropriate Business Unit representative.

• Present data to customers / internal management with ease and without undue hardship.

• Maintain positive external and internal customer relationships with face-to-face, email and voice communication.

• Provide the appropriate feedback within 24 hours of notification.

• Assist with Supplier Investigations as needed.

• Assess and provide detailed reports/summaries on the impact of process changes to PCI management.

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:

• Associate's Degree in a related field and/or 1-3 years related experience and/or training.

• College Level Mathematical Skills

• Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.

• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.

• High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.

Preferred

• Ability to demonstrate attention to detail.

• Ability to work independently and/or part of a team.

• Ability to hold oneself in a professional manner.

• Ability to effectively present information to various people as the job requires.

Join us and be part of building the bridge between life changing therapies and patients.