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 Summary:

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 & Responsibilities:

• 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 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.
• 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, 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.

Special Demands:

• Stationary Position: From 1/2 to 3/4 of the day.
• Move, Traverse: From 1/4 to 1/2 of the day.
• Operate, activate, use, prepare, inspect, or place: From 1/2 to 3/4 of the day.
• Install, place, adjust, apply, measure, use, or signal: None.
• Ascend/Descend or Work Atop: None.
• Position self (to) or Move (about or to): From 1/4 to 1/2 of the day.
• Communicate or exchange information: 3/4 of the day and up.
• Detect, distinguish, or determine: From 1/4 to 1/2 of the day.

On an average day, the individual can expect to move and/or transport up to 10 pounds

between 1/4 and 1/2 of the day.

This position may have the following special vision requirements.

• Close Vision Distance Vision Color Vision Peripheral Vision Depth Perception

Ability to focus No Special Vision Requirements

Work Environment:

The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.

• Work is primarily performed at a desk and/or in an office environment. for 3/4 of the day and up.
• The noise level in the work environment is typically, moderate.

Qualifications:

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.

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