Visual Inspection Technician III

PCI Pharma Services • Bedford, NH

1d • Hybrid

About The Position

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.

Requirements

• 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.
• 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

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

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

Benefits

• 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.
• At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience.
• Our people make all of this happen, so providing an industry leading experience for our people is equally as important.
• By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers.
• We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program.
• We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 1-10 employees