Clinical Quality Documents Coo

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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.

Clinical Quality Documents Coordinator

Department/Group: Clinical QC

Location: Assembly

Reports to: Clinical Quality Manager

FLSA Status: Non-Exempt

Summary Of Objective

Perform required regulatory functions of document control such as clinical document issuance, review and retrieval.

shipments (cold chain and ambient) for clinical distribution.

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.

• Company liaison with customers and internal departments concerning proper documentation technique,
• Conduct documentation training for new Quality Documents Coordinator personnel.
• Audit participation as needed.
• Attends conference calls, CPT and other special project meetings for all assigned projects as needed.
• Responsible for copying, approving and saving label copy in EDOC system.
• Creates master files.

quality control and batch release to meet due dates.

release and randomizations.

• Prepares and distributes required documentation for requested production work orders (including

randomizations).

• Performs

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.

• Maintains and files released WO jackets.
• Helps direct employees to information books, records etc.
• 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
• May perform inspection of individual shipments (cold chain and ambient) for clinical distribution as

needed.

• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• Attendance to work is an essential function of this position
• This position may require overtime and/or weekend work.
• Performs other duties as assigned by Manager/Supervisor.

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Special Demands: The physical demands described here are representative of those that must be met by an

employee to successfully perform the essential functions of this job. The employee must be physically capable to

perform the duties listed below with or without reasonable accommodations which may be made to enable

Individuals With Disabilities To Perform The Essential Functions

• Ascend/Descend or Work Atop: None.
• Position self (to) or Move (about or to): Up to 1/4 of the day.
• Communicate or exchange information: 3/4 of the day and up.
• Move, Traverse: Up to 1/4 of the day.
• Install, place, adjust, apply, measure, use, or signal: None.
• Detect, distinguish, or determine: 3/4 of the day and up.
• Stationary Position: 3/4 of the day and up.
• Operate, activate, use, prepare, inspect, or place: Up to 1/4 of the day.

On an average day, the individual can expect to move and/or transport up to 25 pounds

less than 1/4 of the day.

This position may have the following special vision requirements.

Close Vision Distance Vision Color Vision Peripheral Vision Depth Perception

Ability to focus No Special Vision Requirements

Work Environment: The work environment characteristics described here are representative of those an employee

encounters while performing the essential functions of this job. Reasonable accommodations may be made to

Enable Individuals With Disabilities To Perform The Essential Functions.

The following are some environmental conditions that one may be exposed to on a daily basis and for

various lengths of time.

Work is primarily performed at a desk and/or in an office environment. for 3/4 of the day and up.

Work is performed in areas with moderate risk or discomfort that may require special safety

precautions, such as wearing protective clothing or gear for up to 1/4 of the day.

The noise level in the work environment is typically, quiet.

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

Required

essential functions.

• Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common
• Basic Mathematical Skills

computer programs.

• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels

pertinent to professional needs.

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• 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.

• Other Required Skills.

Preferred

• Ability to effectively present information to various people as the job requires.
• Ability to work independently and/or as part of a team.
• Various Preferences.
• Ability to identify and resolve problems in a timely manner.
• Ability to demonstrate attention to detail.
• Ability to follow instructions and respond to management direction.

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

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.