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Summary of Objective:

The Manufacturing Technician I learns and performs a variety of tasks with su

Summary of Objective:

This position is responsible for performing visual inspection of sterile filled containers (vials) in accordance with all applicable procedures, regulations, and safety directives. This individual's primary job function will be to ensure finished drug product vials manufactured by PCI are free of visible defects which are culled through the visual inspection process to support patient safety and product quality.

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.

* Repetitive handling of sterile filled containers while primarily in a seated position, swirling and inverting containers and extending arm out in front of light source in order to identify product defects.

* Records production quantities and other applicable information with adherence to Good Documentation Practices

* Applies a moderate level of math skills to included piece counting, time calculations, and product reconciliation

* Follows written procedures and document results in a neat and accurate manner according to GMP standards and other regulations

* Performs daily cleaning of visual inspection and packaging areas in accordance with established procedures

* Identifies and communicates product quality issues

* Maintains attention to detail and quality while completing multiple or repetitive tasks and meeting product timelines

* Effectively communicates both verbally and in writing with all levels

* Maintains a high level of integrity while balancing all job responsibilities

* Performs all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice

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.

- 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: Up to 1/4 of the day.

- Install, place, adjust, apply, measure, use, or signal: None.

- Ascend/Descend or Work Atop: Up to 1/4 of the day.

- Position self (to) or Move (about or to): From 1/2 to 3/4 of the day.

- Communicate or exchange information: 3/4 of the day and up.

- Detect, distinguish, or determine: 3/4 of the day and up.

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.

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 essential functions.

Required:

- Minimum of a High school diploma/equivalency.

- 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.

- 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.

- Other Required Skills.

- Able to understand and follow instructions

-Ability to read, understand, follow and comply with technical and written documents (SOPs) written in English

PHYSICAL REQUIREMENTS -

-Must be able to maintain visual qualifications: (20/20 vision corrected or uncorrected checked annually); ability to see all colors and the ability to visually discern product specifications across multiple products

-Must be able to work while wearing PPE for all GMP areas for an entire shift (Includes non-latex gloves, hair\beard covers and lab coats)

COMMUNICATIONS & CONTACTS -

- Interacts with cross functional support teams such as Operations, QA, QC, Engineering, R&D, Validation, etc.

Preferred

- Previous employment within and FDA/USDA, GMP environment

- Ability to effectively present information to various people as the job requires.

- Ability to display excellent time management skills.

- Ability to display a willingness to make decisions.

- Ability to work independently and/or part of a team.

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.

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Join us and be part of building the bridge between life changing therapies and patients.

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.