Quality Coordinator

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.

Summary of Objective:

Assists with coordinating quality activities of a designated Customer Team to ensure that the 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.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Prepares and distributes required documentation for requested production work orders.

• Perform documentation and records review of completed orders to ensure compliance with cGMP and customer requirements.

• Creating and updating batch records, forms, and material specifications as well as organizing internal and customer approval of batch records and specifications.

• Performs and submits batch records, accountability reports, and necessary documentation to customers to facilitate product release.

• Help identify, communicate, track, and resolve document-related issues with other departments and customers.

• Function as one of the customer points for comments or questions about batch documentation.

• Assist with providing quality-related metrics.

• Performs finished product batch release of approved production lots.

• Meet with management to address issues or concerns with the batch documentation.

• Reviews and interprets customer standards, procedures, and specifications for dissemination relative to batch records, forms, and material specifications. Organize internal and customer approval of batch records and specifications.

• This position may require overtime and/or weekend work.

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

• Attendance to work is an essential function of this position

• Performs other duties as assigned by Manager/Supervisor.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Required:

• TABE testing requirements met at the approved grade level for the position.

• Basic 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.

• Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.

Preferred

• Ability to follow instructions and respond to management direction.

• Ability to identify and resolve problems promptly.

• Ability to hold oneself professionally.

• Ability to demonstrate attention to detail.

• High School Diploma or GED

• 2 years of experience in Operations/Quality and/or providing support in an office or manufacturing environment.

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Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.