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Job Summary:

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 & 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.

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

NOTE: Employees who have received a counseling report for a violation occurring within the last 3 months are not eligible to apply for open positions

Work Environment:

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.

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

Qualifications:

Required:

• TABE testing requirements met at approved grade level for position.

• Basic Mathematical Skills

• Intermediate Computer Skills: 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

• 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. .

Please note that you must be in your current position for a minimum of 6 months and in good standing to be eligible to apply for other internal positions.

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