As a ProMed employee, you will contribute to the manufacture of products that have a significant impact on people’s lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best.
ProMed was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well-being of people around the world.
Working as one to help many.
POSITION SUMMARY
The Quality Technician is responsible for day-to-day administration and support as applicable to the organization’s environmental monitoring, preventative maintenance and calibration, facilities control, material management, pharmaceutical operations and cleaning verification/validation. This position operates under minimal guidance from management or senior staff. The Quality Technician ensures ProMed’s brand, philosophy, systems, policies, and procedures are properly implemented and observed.
ESSENTIAL DUTIES & RESPONSIBILITIES
Position duties and responsibilities include, but are not limited to the following:
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Perform and document routine environmental monitoring of cleanrooms and controlled areas and test/send samples to approved testing laboratories.
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Interpret sampling results, maintain trending spreadsheets, and complete data review forms.
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Author (annual) trend reports.
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Standardize/Assist with updating sampling maps in the event of room changeover.
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Coordinate with Facilities for scheduling of and accompany cleanroom certification/testing contractors.
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Maintain inventory of consumable testing supplies, submit purchase requisitions to restock.
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Monitor DicksonOne and address/assist with any excursions.
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Review and trend preventative maintenance and calibrations.
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Review and trend pest control logs, vendor reports and issues.
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Perform cleaning verification/validation swabbing and submit samples to analytical lab for testing.
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Perform sampling of materials for QC testing, retains, and retesting.
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Assist with incoming material inspection records.
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Assist in updating or revision SOPs/forms/templates for clarity and accuracy.
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Review of logbooks.
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Assist with line clearance and checks.
OTHER RESPONSIBILITIES
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Identify and escalate gaps, inconsistencies, or potential compliance risks within the QMS to the QA Manager.
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Participate in internal audits and self-inspections as assigned; support corrective action follow-up activities.
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Support the implementation of regulatory changes and quality system improvements as directed;
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Assist in preparing responses to audit observations or regulatory findings that involve document or records management.
This job also requires performing other duties as assigned.
QUALIFICATION, EDUCATION & EXPERIENCE
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required:
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Bachelor’s degree in Life Sciences, Chemistry, Microbiology, or a related field.
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0-3 years of experience in a regulated industry (pharmaceutical or biotech).
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Knowledge of GMP principles and FDA regulatory requirements (21 CFR Parts 210/211 and/or 820).
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Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
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Knowledge of ALCOA+ data integrity principles.
Preferred:
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Familiarity with eQMS platforms (e.g., MasterControl, Veeva Vault, Agile, TrackWise) even if primary system is paper-based.
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Experience with EU GMP, ICH Q7, ICH Q2(R1), and/or ISO 13485 requirements.
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Ability to work autonomously, effectively manage time and deliver results on time.
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Attention to detail and commitment to data integrity and accuracy in all quality records.
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Effective written and verbal communication skills; ability to clearly document processes, decisions, and deviations.
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Strong organizational skills with the ability to manage multiple priorities, deadlines, and document workflows simultaneously.
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Collaborative mindset with the ability to work cross-functionally with operations, R&D, and other QA functions.
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Comfort working in a structured, compliance-driven environment with defined SOPs and change control requirements.
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Proactive problem-solving skills; escalates issues appropriately and follows through on assigned action items.
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Aptitude for learning and applying regulatory requirements and quality standards.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the principal roles and responsibilities of this job:
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Exposure to heated/air conditioned, ventilated facilities with florescent lighting;
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Exposure to building where a variety of chemical substances are used for cleaning, and/or operation of equipment;
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The noise level in the work environment is usually minor;
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Duties are performed indoors;
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Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
PHYSICAL, SENSORY, COGNITIVE & NEUROLOGICAL DEMANDS
While performing the duties of this job:
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The employee may be required to stoop, bend, squat, kneel, reach, stand, walk, lift, pull, push, grasp, talk, hear, see and use repetitive motions;
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Specific vision abilities required include close vision such as to read handwritten or typed material and the ability to adjust focus;
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The position requires the individual to meet multiple demands from several people and interact with internal and external people;
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Employee moves about the building and be able to maneuver in tight spaces between desks, etc.;
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Employee may have duties involving walking on even or uneven surfaces;
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Employee occasionally to frequently use a whiteboard, which can require grasping whiteboard pens, reaching at, below, or above shoulder height and may require trunk or neck rotation to look back;
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Employee may use computers, overhead projectors, TV, and other work-related equipment, which may require an approximately 25+ pound force to push or pull equipment;
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It is necessary to grasp and manipulate pens, markers, scissors, staplers, etc. occasionally to frequently;
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Employee must see and hear on a continuous basis as well as speak frequently;
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Position varies from standing, sitting, walking, etc. On some occasions it may be necessary to move quickly, run, etc. over smooth or uneven surfaces.
ProMed offers a generous benefits package including:
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401k with company match
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Profit Sharing Program
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Medical Insurance
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Health Savings Account/Flexible Spending Account
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Dental Insurance
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Vision Insurance
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Life Insurance
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Paid Family Medical Leave and Long-Term Disability Insurance
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Hospital Indemnity, Critical Illness, Accident, and Identity Theft Protection
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Pet Insurance
ProMed does not discriminate in employment opportunities or practices on the basis of race, color, creed, religion, national origin, ancestry, age, sex, marital status, order of protection, disability, military status, sexual orientation, gender identity, pregnancy, public assistance, family status, unfavorable discharge from military service, genetic information or other segmenting factor protected by law, or local human rights commission activity.
