Visual Inspection Technician I/II/III

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.

JOB DUTIES

• 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

PROFESSIONAL SKILLLS

• 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.

EXPERIENCE

• 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

EDUCATION

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

QUALITIES

* 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

* 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

PHYSICAL REQUIREMENTS & MENTAL DEMANDS

Lifting/Pushing/Pulling - note # Lbs.

Up to 20 lbs.

Walking

< 25% of the time

Standing

< 25% of the time

Bending

< 25% of the time

Stooping

< 25% of the time

Kneeling

< 25% of the time

Sitting

50% of the time

Driving

Occasional <25%

Additional:

• 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

COMMUNICATIONS & CONTACTS

• 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 facilities to carry out duties

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.

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.