Visual Inspection Technician I

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 -

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.

JOB DUTIES -

• 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 include 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

• Acquires and maintains qualifications to inspect one to two types of product (i.e. clear lyophilized product, clear liquid product, Opaque product, etc.)

• 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

• Supports finished product packaging operations

• 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

PROFESSIONAL SKILLS -

• Basic computer skills are required.

• Able to understand and follow instructions

EXPERIENCE -

• High school diploma or equivalent required

• Previous experience with GMP's, SOP's and working in an FDA / EU regulated environment is desired

EDUCATION -

• High school diploma or equivalent required

QUALITIES -

• Attention to detail

• Basic verbal and written skills

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

• 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)

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

Kneeling < 25% of the time

Sitting ≥ 75% of the time

Additional:

• Able to follow written instructions

• Able to communicate with peers in a professional manner

• Able to work as a team

COMMUNICATIONS & CONTACTS -

• Interacts with all Visual Inspection staff on a daily basis

• Communicates and Collaborates with Quality, Materials Management departments and other departments as needed.

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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.