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Freelance Medical Device Labeling Jobs in Wisconsin

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Freelance Medical Device Labeling information

What is freelance medical device labeling?

Freelance medical device labeling involves independent professionals who create, review, and manage the labels and instructions that accompany medical devices. These labels must meet strict regulatory requirements to ensure patient safety and regulatory compliance. Freelance specialists may work with manufacturers to develop compliant packaging, user manuals, and product inserts for various markets. They need to be knowledgeable about international regulations and guidelines, such as those from the FDA or the European MDR. This role often requires attention to detail, regulatory expertise, and clear communication skills.

What are some common challenges freelance medical device labeling specialists face when collaborating with multiple clients?

Freelance medical device labeling specialists often navigate varying regulatory requirements and documentation standards from different clients, which can be challenging. Each client may use different systems for document management and have unique internal review processes, requiring adaptability and strong organizational skills. Additionally, balancing multiple projects with tight deadlines demands effective time management to ensure all labeling materials remain compliant and up to date. Proactive communication and a thorough understanding of regional regulations are crucial for successful collaboration and project delivery.

What are the key skills and qualifications needed to thrive as a freelance medical device labeling specialist?

To thrive as a Freelance Medical Device Labeling Specialist, you need expertise in regulatory requirements, medical terminology, and technical writing, often supported by a background in life sciences or regulatory affairs. Familiarity with labeling management systems, document control software, and knowledge of FDA, EU MDR, or ISO standards is typically required. Attention to detail, strong organizational skills, and clear communication are essential soft skills to ensure accuracy and compliance. These skills are critical for producing precise, regulation-compliant labeling that ensures patient safety and successful product approval.

What are the most commonly searched types of Medical Device Labeling jobs in Wisconsin?

The most popular types of Medical Device Labeling jobs in Wisconsin are:

What are popular job titles related to Freelance Medical Device Labeling jobs in Wisconsin?

For Freelance Medical Device Labeling jobs in Wisconsin, the most frequently searched job titles are:

What job categories do people searching Freelance Medical Device Labeling jobs in Wisconsin look for?

The top searched job categories for Freelance Medical Device Labeling jobs in Wisconsin are:

What cities in Wisconsin are hiring for Freelance Medical Device Labeling jobs?

Cities in Wisconsin with the most Freelance Medical Device Labeling job openings:

Freelance Medical Device Labeling jobs near you

Drug Product Manufacturing Technician

PCI Pharma Services

Madison, WI • On-site

Full-time

Re-posted 27 days ago

PCI Pharma Services rating

6.7

Company rating: 6.7 out of 10

Based on 42 frontline employees who took The Breakroom Quiz

439th of 540 rated manufacturers

Job description

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.
The Drug Product Manufacturing Technician learns and performs a variety of tasks with supervision and in accordance with the manufacturing instruction set inclusive of current GMP/ISO requirement and standards and following all safety guidelines of PCI. With supervision, the technician performs routine and critical manufacturing operations, including but not limited to work functions in equipment prep, formulation, aseptic compounding, and filling activities for biopharma and medical device products. Works with Master production records and standard operating procedures. Conducts self in accordance with the Guardian values and behaviors.
*Hiring various levels based on relevant experience
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
  • Maintains and adheres to safe work habits and all applicable PCI safety procedures and guidelines.
  • Demonstrates general knowledge of aseptic techniques.
  • Prepares solutions, aseptic filling, and labeling of vials under sterile and non-sterile conditions, routine solution and filtration, vial and component preparation and sterilization.
  • Assembles, disassembles, and operates aseptic filling equipment and lyophilizer equipment in classified cleanroom and controlled non classified environments. Operates vial capper, unloads product from lyophilizers and liquid fill line.
  • Prepares equipment and components for sterilization and Lyophilization.
  • Operates processing equipment including autoclaves, ovens, vial washers, and depyrogenation, centrifuges, mills equipment.
  • Assists in the formulation and dispensing of product in a clean room environment per SOPs and MBRs
  • Sanitizes production areas and prepares equipment for production.
  • Completes and maintain documentation related to assigned work, including logbooks, batch records, etc.
  • Adheres to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.
  • Identifies, escalates and documents events that deviate from normal operation; participate as needed in investigations.
  • Maintains compliance, cleanliness and orderliness of operational areas per appropriate SOPs.
  • Performs COP, CIP, and SIP operations to prepare equipment for manufacturing operations.
  • Reviews and revises pertinent SOPs and production batch records as required.
  • Inspire and constantly strive to make PCI a great place to work and respected for the quality of its people and products and clients.
  • Successfully participates in media fill/aseptic proficiency test

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.
  • Ability to wear personal protective equipment such as safety glasses/goggles, gloves, and safety shoes.
  • Ability to gown and gain entry to controlled manufacturing areas.
  • Ability to lift, pull or push equipment requiring up to 25-50 lbs of force.
  • Ability to stand for 6 hours in a production suite.
  • Ability to work any shift (up to 10 hours) as required dependent on business needs.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Interacts with cross functional support teams such as Operations, QA, QC, Engineering, R&D, Validation, etc.
  • This is an individual contributor role.

TRAVEL - <10%
  • Ability to adapt to a changing process daily (i.e., Formulations vary depending on client product)
  • Able to work under the scrutiny of clients daily
  • Expected to be flexible with the process and adjust work hours accordingly

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • 0 - 2+ years of working experience, preferably in a manufacturing environment ideally in the pharmaceutical or medical device industry.
  • Minimum of a High school diploma/equivalency.
  • Ability to weigh and measure raw materials and operate basic Benchtop instruments.
  • Able to follow written instructions. Seeks help with more complex and non-routine tasks.
  • Ability to adapt to a changing process daily (i.e., Formulations vary depending on client product)
  • Able to work under the scrutiny of clients daily
  • Expected to be flexible with the process and adjust work hours accordingly
  • Good verbal and written skills
  • Pay attention to detail. Demonstrates a good mechanical aptitude.
  • Commits to conducting PCI business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of PCI products and services.
  • Honesty, integrity, respect and courtesy with leadership and peers
  • Openly receives and implements feedback, resilient, able to move past mistakes; applies learning.
  • Self-starter, able to work in a fast dynamic work setting

#LI-LL1
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.

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