Quality Coordinator

PCI Pharma Services

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

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 : Assist with coordinating quality activities of a designated Customer Focused Team to ensure goals and objectives of the team are accomplished within prescribed time frames and in budget. Helps drive projects 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 following are the essential duties and responsibilities of this position, 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's 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 pertaining to 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, 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 the essential functions.

Preferred : Ability to follow instructions and respond to management direction.

For candidates in Illinois : The hiring rate for this position is $18.15 -$20.42 hourly plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).