Associate Quality Account Mgr

PCI Pharma Services•Rockford, IL

7d•$51,120 - $57,510•Onsite

About The Position

The Associate Quality Account Manager assists with coordinating quality activities for a designated Customer Focused Team, helping ensure team goals and objectives are completed within prescribed time frames and budget. The role supports project success and long-term quality customer management by maintaining compliant batch record documentation and material specifications, facilitating customer questions about batch record review and documentation updates, and sustaining positive relationships with internal and external customers. The position reviews, creates, and updates master batch records, forms, and specifications; supports order-record reviews and finished-product batch release; and acts as a liaison with customers on quality-control documentation. It also contributes to quality-event and deviation investigations, annual product review data, performance metrics, training and mentoring, inspections, supplier investigations, and assessments of process changes. The role may require overtime and weekend work and requires adherence to PCI, cGMP, and GCP policies and procedures. Work is primarily performed at a desk and/or in an office for three-quarters of the day or more. The noise level is typically moderate. The position is based at PCI’s Linden Road location in Rockford, Illinois, and is on first shift.

Requirements

Associate’s degree in a related field and/or 1–3 years of related experience and/or training.
College-level mathematical skills.
Intermediate computer skills, including the ability to perform more complex computer tasks and knowledge of various computer programs.
Full professional proficiency: ability to speak, read, and write fluently and accurately at levels pertinent to professional needs.
High reasoning ability to solve practical problems, deal with concrete variables in situations with limited standardization, and interpret instructions presented in various forms.

Nice To Haves

Attention to detail.
Ability to work independently and/or as part of a team.
Ability to conduct oneself professionally.
Ability to present information effectively to various audiences.

Responsibilities

Review master batch records, forms, and specifications to verify they meet internal and customer standards, procedures, and requirements.
Help create and update batch records, forms, and material specifications, and coordinate internal and customer approvals.
Help review records for completed and in-process orders for compliance with cGMPs and customer requirements.
Serve as a company liaison with customers regarding quality-control documentation, and help identify, communicate, track, and resolve document-related issues.
Perform finished-product batch release for approved production lots.
Attend customer calls and meetings and provide complaint- and quality-related information.
Help prepare annual product review data.
Help generate and present quality metrics and key performance indicators for team performance.
Help investigate quality deviations and draft associated investigation reports.
Help address and document quality events with Production and Quality teams.
Help train, develop, and mentor new Quality Coordinators.
Develop, update, and implement procedural changes throughout the organization.
Standardize documentation to support PCI’s quality standards across its customer base.
Coach, train, mentor, and develop employees to ensure quality standards are met and maintained.
Schedule, host, and lead meetings to develop, implement, or update batch records, material specifications, forms, work practices, and standard operating procedures.
Help with in-process and finished-goods inspections, annual retain inspections, customer complaint samples, or rework as needed.
Compile, update, and analyze customer and internal data and metrics to identify trends and opportunities; use Microsoft Office Suite to present data professionally.
Support the RIT investigation process through online interactions with Operations staff and summarize findings for the appropriate Business Unit representative.
Present data to customers and internal management.
Maintain positive internal and external customer relationships through face-to-face, email, and voice communication, and provide appropriate feedback within 24 hours of notification.
Help with supplier investigations as needed.
Assess and provide detailed reports or summaries on the impact of process changes to PCI management.
Adhere to PCI, cGMP, and GCP policies, procedures, and rules; maintain attendance and perform other duties assigned by the Manager or Supervisor.
Work overtime and/or weekends when required.