Associate Quality Account Mgr

PCI Pharma Services•Rockford, IL

5d•Onsite

About The Position

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.

Requirements

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 3 situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.

Nice To Haves

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.

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