Visual Inspection Technician II

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. Other job functions include sampling, packaging, and labeling finished product vials in accordance with cGMP's and established SOP's.

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 included 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 two or more 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 data entry for product specific metrics by utilizing current systems

• Reviews completed documentation and provides recommendation for process improvements to support existing procedures for continual improvement in conjunction with department supervisor.

• Capable of supporting sampling, packaging, and labeling operations at multiple sites with minimal supervision.

• Performed GMP tasks by executing steps as written through established procedures with minimal supervision.

• Effectively communicates both verbally and in writing with all levels

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

• 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

• Able to communicate with coworkers and management in a professional manner

EXPERIENCE

• 2+ years of 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)

• Seeks guidance and clarification for more complex or non-routine tasks

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.

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.