Bedford, NH, USA
33 days ago
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.

   

                                                                                                                                    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 PracticesApplies a moderate level of math skills to included piece counting, time calculations, and product reconciliationFollows written procedures and document results in a neat and accurate manner according to GMP standards and other regulationsAcquires 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 proceduresIdentifies and communicates product quality issuesMaintains attention to detail and quality while completing multiple or repetitive tasks and meeting product timelinesSupports finished product packaging operationsEffectively communicates both verbally and in writing with all levelsMaintains a high level of integrity while balancing all job responsibilitiesPerforms all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practicePROFESSIONAL SKILLS –  Basic computer skills are required. ·Able to understand and follow instructions EXPERIENCE –  High school diploma or equivalent requiredPrevious 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 detailBasic verbal and written skillsAbility to read, understand, follow and comply with technical and written documents (SOPs) written in EnglishMust 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 productsMust 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 instructionsAble to communicate with peers in a professional mannerAble to work as a team

COMMUNICATIONS & CONTACTS – Interacts with all Visual Inspection staff on a daily basisCommunicates 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

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.

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