Visual Inspection Technician I/II/III
About The Position
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. 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. JOB SUMMARY 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 will be responsible for the upkeep of departmental key performance indicators (KPIs) for Management Review reporting.
Requirements
- 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.
- 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.
- High School graduate with relevant experience in sterile product manufacturing or visual inspection (3-5 years) or related experience.
- 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
Nice To Haves
- 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
- Work 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
- 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
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
