What are the responsibilities and job description for the Labeling Specialist position at Maxx Orthopedics Inc.,?
About Us:
Maxx Orthopedics develops and manufactures innovative joint replacement products designed to address the needs of today’s diverse patient population. At Maxx Orthopedics, our goal is to help patients Pursue Life®. We passionately believe that orthopedic surgeons should be equipped to deliver exceptional and repeatable results for their patients.
POSITION SUMMARY
The labeling specialist will demonstrate application of Quality policies and procedures, projects, and systems used for Maxx Orthopedics, Inc. product labels. This individual will liaise with various departments to ensure label compliance for new product innovation and revisions to existing labels for products manufactured by all Maxx Orthopedics, Inc. owned and contracted facilities marketed globally.
ESSENTIAL FUNCTIONS
Reasonable Accommodations Statement
To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.
Essential Functions Statements(s)
- Interacting with contract manufacture customers on issues relating to labeling; builds and maintains professional and effective rapport with clients resulting in enhanced business relationships.
- Performing review of draft and final labeling for compliance with applicable global and FDA requirements. Responsible for maintaining an error-free environment with respect to all labelling components and documentation.
- Maintaining labeling files for current / historical components and updates databases for current components, maintains current label sample files.
- Serves as primary contact within the working teams for planning, startup, and execution of the label development activities through the label review system.
- Works independently and with minimal supervision. Provides the necessary support to team members to foster a collaborative and inclusive work environment.
POSITION QUALIFICATIONS
Experience:
- Associate or Bachelor’s degree preferred in a related discipline.
- 2-4-years of working experience preferably in a highly regulated environment like the medical device industry
Required Skills/Abilities:
- Preferred knowledge of applicable global standards and regulations.
- Dynamic team player with initiative, drive, and an aptitude for problem-solving.
- Working knowledge of relational databases.
- Excellent written and oral communication skills.
- Excellent project and vendor management skills.
- Computer literacy and skills in, but not limited to, MS Office (Excel, Word, PowerPoint).
Office Environment
PHYSICAL DEMANDS
N (Not Applicable) Activity is not applicable to this position.
O (Occasionally) Position requires this activity up to 33% of the time (0 - 2.5 hrs/day)
F (Frequently) Position requires this activity from 33% - 66% of the time (2.5 - 5.5 hrs/day)
C (Constantly) Position requires this activity more than 66% of the time (5.5 hrs/day)
Physical Demands
Stand O
Walk O
Sit C
Manually Manipulate O
Grasp N
Reach Outward N
Reach Above Shoulder N
Speak C
Climb N
Crawl N
Squat or Kneel O
Bend O
Lift/Carry
10 lbs or less O
11-20 lbs O
21-50 lbs O
51-100 lbs N
Over 100 lbs N
Push/Pull
12 lbs or less O
13-25 lbs N
26-40 lbs N
41-100 lbs N
Other Physical Requirements
Vision (Near)
WORK ENVIRONMENT
Office Environment
The success of our organization relies on the kind of creative thinking that can only result from a diverse team of individuals. Maxx Orthopedics is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. EOE.
Job Type: Full-time
Expected hours: 40 per week
Benefits:
- 401(k) matching
- Flexible schedule
Schedule:
- Monday to Friday
Application Question(s):
- What are your salary requirements?
Experience:
- Manufacturing: 1 year (Preferred)
Shift availability:
- Day Shift (Preferred)
Ability to Commute:
- Norristown, PA 19403 (Required)
Work Location: In person