At Shire, we are proud and grateful to employ military veterans and thank them for their contributions to our company and our country. See where your military experience can play a role at Shire by using our military skills translator job search tool below:
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 –
· 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 –
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.
LI#HA1
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.
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