PCI Pharma Services · 4 weeks ago
Clinical Quality Documents Coordinator
Rockford, IL
Full-time
Onsite
New Grad, Entry Level
$18.15/hr - $20.42/hrPCI Pharma Services is a company focused on life changing therapies and global impact. They are seeking a Clinical Quality Documents Coordinator to perform regulatory functions of document control and maintain clinical documents in accordance with cGMP’s.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
Creates master files
Responsible for copying, approving and saving label copy in EDOC system
Attends conference calls, CPT and other special project meetings for all assigned projects as needed
Conduct documentation training for new Quality Documents Coordinator personnel
Audit participation as needed
Company liaison with customers and internal departments concerning proper documentation technique, quality control and batch release to meet due dates
Company liaison with PCI UK Qualified Persons (QP’s) and PCI US concerning quality control batch release and randomizations
Prepares and distributes required documentation for requested production work orders (including randomizations)
Performs documentation review of completed orders to ensure compliance with cGMP’s and customer requirements (includes WO, receiving reports, retain photographs and randomization files)
Prepares and submits executed Batch Records, accountability reports and necessary documentation to customers to facilitate product release
Helps direct employees to information books, records etc
Maintains required Quality Metrics (WO’s) on a routine basis
Maintains and files released WO jackets
Helps identify, communicate, track, and resolve document related issues with other departments and customers
Helps identify, communicate, track, and resolve document related issues with other departments and customers
May develop, write, revise and review work practices and forms in accordance with PCI and GMP requirements
Verify changes adhere with SOP’s, WP’s and customer requirements
May perform inspection of individual shipments (cold chain and ambient) for clinical distribution as needed
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
Qualification
Required
Basic Mathematical Skills
Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs
Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations
Preferred
Ability to effectively present information to various people as the job requires
Ability to follow instructions and respond to management direction
Ability to identify and resolve problems in a timely manner
Ability to work independently and/or as part of a team
Ability to demonstrate attention to detail
Benefits
Paid time off
Health insurance coverage (including dental and vision)
Flexible spending account
401(k)
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
Founded in 2012
5001-10000 employees
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 StageTotal Funding
unknown2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase