at PCI Pharma Services Ohio, LLC in Rockford, Illinois, United States Job Description 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.
Position Title:
Quality Coordinator Location:
Rockford, Assembly Drive Department:
Business Unit-QC Shift:
1st
Reporting To:
Associate Quality Account Manager Responsible For (Staff): no Assists with coordinating quality activities of a designated Customer Focused Team to ensure that 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
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.
Special Demands:
Stationary Position:
3/4 of the day and up.
Move, Traverse:
From 1/4 to 1/2 of the day. Operate, activate, use, prepare, inspect, or place: From 1/2 to 3/4 of the day. Install, place, adjust, apply, measure, use, or signal: None.
Ascend/Descend or Work Atop:
None. Position self (to) or Move (about or to): From 1/4 to 1/2 of the day.
Communicate or exchange information:
3/4 of the day and up. Detect, distinguish, or determine: Up to 1/4 of the day. On an average day, the individual can expect to move and/or transport up to 10 pounds less than 1/4 of the day.
Required:
TABE testing requirements met at approved grade level for position.
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 Preferred:
Ability to follow instructions and respond to management direction. Ability to identify and resolve problems in a timely manner. Ability to hold oneself in a professional manner. 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. . Equal Opportunity Employer/Vet/Disabled Join us and be part of building the bridge between life changing therapies and patients. LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company's EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company. To view full details and how to apply, please login or create a Job Seeker account
