Functional Test Lab Technician

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

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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.

Functional Test Lab Technician

Locations:

Rockford - Linden

1st Shift

Summary of Objective:

The Functional Test Lab Technician performs the duties and tasks under the supervision and as assigned by the Senior Manager of the Functional Test Laboratory. This role will involve functional testing of finished products, assembled at PCI Pharma Services. It will also include operating and maintaining laboratory testing equipment to ensure testing is performed only using validated programs and following PCI’s standard operating procedures (SOPs), work instructions (WIs), and/or other relevant job aids and standard requirements for data reliability, product safety, and efficacy.

This role must adhere to specific guidelines, rules, and regulations to ensure compliance with applicable standards and requirements for release testing finished products. It will interact with and communicate information with multiple departments. No supervisory duties are required for this position.

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.
• Read, understand, and execute functional laboratory testing procedures.
• Conduct quality inspections of finished products to determine approval, hold, or rejection status.
• Operate, maintain, and troubleshoot functional testing equipment and analyze data results.
• Complete documentation following the company's Quality Management System guidelines and all applicable federal, state, and regulatory requirements.
• Can make an appropriate disposition of results based on observations. Participate in comprehensive training programs that include reading procedures, on-the-job training, video training, and other relevant training methods.
• Must be an effective team player who actively participates and cooperates with others to improve the overall quality of our processes.
• Proactively follows up internally to secure missing documentation, ensuring all Quality expectations and parameters are met and testing of the material is expedited.
• This position may require overtime and/or weekend work. Supports company strategic, departmental operational excellence, and manufacturing regulatory initiatives. 
• Represents Quality on assigned project teams and leads projects relevant to Quality.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules. Attendance at work is an essential function of this position. Performs other duties as assigned by the Manager/Supervisor.

Qualifications: The requirements listed below are representative of the knowledge, skills, and/or abilities required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• High School Diploma or GED and/or 3-5 years related experience and/or training.

• Basic Mathematical Skills
• Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs.   
• Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers.
• 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.
• Driver's License

Preferred

• Ability to demonstrate attention to detail.
• Ability to display excellent time management skills.
• Ability to follow instructions and respond to management direction.
• Ability to identify and resolve problems promptly.    

For candidates in Illinois: The hiring rate for this position is $18.15 to $22.69 hourly, plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subj