Visual Inspection Technician III

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.

Summary of Objective:

Responsible for supporting the timely product inspection, documentation, and bulk packing of sterile clinical and commercial products following cGMP's and in-house SOP's. This will be accomplished by working with Visual Inspection management to assist with the supplemental USP <790> reconstitution testing, identification and characterization of particulate matter defects, documentation review and revision. This individual will also be responsible for the upkeep of departmental key performance indicators (KPIs) for Management Review reporting.

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.

* Support Visual Inspection, Packaging and Labeling of product as needed across multiple sites with minimal to no supervision.

* Supports development and tracking of metrics (KPI's) relating to defect rate, inspection throughput, on time delivery and right first-time.

* Acquires and maintains qualifications to inspect all types of product (i.e. clear lyophilized product, clear liquid product, Opaque product, etc.) to support the demands of the production schedule.

* Support the training of employees on difficult to inspect final products and supplemental visual inspection qualifications

* Performs department specific, and reviews other relevant document changes within the Master Control system.

* Supports Quality System Event investigations (Event Reports / Deviations / CAPAs) and works with VI management to determine probable root cause.

* Support implementation of identification and characterization of particulate matter defects

* Support supplemental reconstitution testing per USP <790>

* Effectively communicates both verbally and in writing with all levels

* Perform setup and operation of production equipment including; inkjet printer, fully automated labeler, label printer and label counter

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

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.

* 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

* Able to deal with ambiguity

* Able to translate ideas to actual concepts and processes

* Able to follow written instructions

* Able to train others

* Able to work as a team

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.

* Communicates and Collaborates with Teammates on a daily basis

* Communicates and Collaborates with other departments such as Quality, Operations, Validations and Facilities staff

TRAVEL Expected to travel between Bedford campus facilities to carry out duties

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.

* 3-5 years of experience with inspection and manufacturing equipment and processes that comply with regulatory requirements.

* Experienced with GMP's, SOPs and working within an FDA / EU regulated environment.

* Experience with Visual Inspection and or labeling and packaging of Pharmaceutical final products, medical device, and/ or combination products a plus

* Prior lab experience a strong plus

* High School graduate with relevant experience in sterile product manufacturing or visual inspection (3-5 years) or related experience.

* Proficient with MS Office suite (Word / Excel / Access).

* Ability to understand VI Concepts, methodologies and regulations.

* Ability to motivate, train less experienced staff.

* Strong communication skills both verbal and written.

* At ease working across multiple departments to achieve goals and objectives

* Team oriented and highly collaborative

* Strong initiative with a drive to results

* Highly attentive and organized with documentation

* Commits to conducting PCI business according to the highest legal and ethical standards, and to continually pursue excellence in all work activities and in the delivery of PCI products and services

* Honesty, integrity, respect and courtesy with leadership and peers

* Openly receives and implements feedback, resilient, able to move past mistakes; applies learning

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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.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.