Associate Quality Account Mgr
About The Position
The Associate Quality Account Manager assists with coordinating quality activities for a designated Customer Focused Team, helping ensure team goals are accomplished within prescribed time frames and budget. The role supports project success and long-term quality customer management by maintaining and updating batch record documentation and material specifications to meet compliance standards, facilitating customer questions about batch record reviews and documentation updates, and maintaining positive internal and external customer relationships. This position reviews and updates quality documentation, supports record review and batch release, and assists with quality investigations, customer meetings, metrics, inspections, training, and process improvements. Work is primarily performed at a desk and/or in an office environment for three-quarters of the day or more; the typical noise level is moderate. The role may require overtime and/or weekend work.
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 all levels pertinent to professional needs.
- High reasoning ability, including solving practical problems involving a variety of concrete variables with limited standardization and interpreting instructions provided 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 effectively present information to various people as required by the job.
Responsibilities
- Review master batch records, forms, and specifications to ensure they meet internal and customer requirements, standards, and procedures.
- Assist in creating and updating batch records, forms, and material specifications, and coordinate internal and customer approvals.
- Assist with reviewing 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; identify, communicate, track, and resolve document-related issues with departments and customers.
- Perform finished-product batch release for approved production lots.
- Attend customer conference calls and meetings and provide complaint and quality-related information.
- Assist in preparing annual product review data.
- Assist with generating and presenting quality metrics and team performance indicators.
- Assist with investigations of quality deviations and draft related investigation reports.
- Assist Production and Quality teams in addressing and documenting quality events.
- Assist with training, developing, and mentoring new Quality Coordinators.
- Follow PCI, cGMP, and GCP policies, procedures, and rules.
- 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.
- Assist with in-process and finished-goods inspections, annual retain inspections, customer complaint samples, and rework as needed.
- Compile, update, and analyze customer and internal data and metrics to identify trends and opportunities; use Microsoft Office Suite to present information 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 in-person, email, and voice communication, and provide appropriate feedback within 24 hours of notification.
- Assist with supplier investigations as needed.
- Assess process changes and provide detailed reports or summaries of their impact to PCI management.
- Perform other duties as assigned by a Manager or Supervisor; maintain attendance as an essential function of the position.
Benefits
- Paid time off.
- Health insurance coverage, including dental and vision.
- Flexible spending account.
- 401(k).
- Eligibility for an annual performance bonus.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
