Job Information
PCI Pharma Services Visual Inspection Technician I in Bedford, New Hampshire
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.
Revision date: 25Nov2020
JOB TITLE: Visual Inspection Technician – Level I LEVEL: Non-Exempt
DEPARTMENT NAME: Visual Inspection REPORTS TO: Supervisor – Visual Inspection
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 LSNE 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 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 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.
MANAGERIAL & SUPERVISORY RESPONSIBILITIES – Not Applicable
TRAVEL – Not Applicable
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)
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, Diversity, Equity, and Inclusion (DEI) 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.
Why work for PCI Pharma Services?
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.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
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