Clinical Quality Documents Coo

PCI Pharma Services • Rockford, IL

2d • $18 - $20

About The Position

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. Job Description Perform required regulatory functions of document control such as clinical document issuance, review and retrieval. Prepares clinical master files and label copies. Liaises with customers, internal departments (US and UK) and QP’s. Create and maintain clinical documents in accordance with cGMP’s. May perform inspection of individual shipments (cold chain and ambient) for clinical distribution.

Requirements

• 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.

Nice To Haves

• 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.

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.

Benefits

• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed