Associate Quality Account Manager jobs in United States
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PCI Pharma Services · 4 days ago

Associate Quality Account Manager

PCI Pharma Services is a company focused on life changing therapies and global impact. They are seeking an Associate Quality Account Manager to coordinate quality activities for a Customer Focused Team, ensuring compliance and successful project outcomes while maintaining positive relationships with customers.

BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
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H1B Sponsor Likelynote

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

Qualification

CGMP complianceBatch Record DocumentationQuality metrics analysisComputer SkillsMathematical SkillsProfessional communicationAttention to detailTeamwork

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

Benefits

Paid time off
Health insurance coverage (including dental and vision)
Flexible spending account
401(k)

Company

PCI Pharma Services

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PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.

H1B Sponsorship

PCI Pharma Services has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (2)

Funding

Current Stage
Late Stage
Total Funding
unknown
2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed

Leadership Team

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Gil Valadez
Chief Operating Officer
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Company data provided by crunchbase