...maintain a safe environment for all employees, residents, families, and visitors, Stellar strongly encourages its employees to receive an FDA-approved COVID-19 vaccination, as well as any subsequent booster doses, as recommended by the Centers for Disease Control and...
Suggested
Hourly pay
Holiday work
Full time
Part time
Local area
Flexible hours
Shift work
...transportation to/from work
Must successful complete and pass a criminal and employment background screening that meets the allowable FDA requirements and is in accordance with EEOC rules and regulations
Must successfully pass a pre-internship drug screen...
Suggested
Contract work
Part time
Internship
Summer internship
Local area
Work from home
Work visa
...groundbreaking, full-body Electro-Muscle Stimulation (EMS) workout that is designed to enhance your fitness at every stage of life. Our FDA-cleared EMS technology works with your body rather than against it, delivering personalized and efficient strength, power, cardio,...
Suggested
Full time
2 days per week
...transportation to/from work
Must successful complete and pass a criminal and employment background screening that meets the allowable FDA requirements and is in accordance with EEOC rules and regulations
Must successfully pass a pre-internship drug screen
PHYSICAL...
Suggested
Contract work
Part time
Internship
Summer internship
Local area
Work from home
Work visa
...Responsible for gym walk-thru as designated in walk-thru log.
Follow proper opening and closing procedures as instructed in the FDA training manual.
Logs all maintenance concerns that are reported.
Follows and reports any safety concerns.
Notifies management...
Suggested
Holiday work
Immediate start
Flexible hours
...groundbreaking, full-body Electro-Muscle Stimulation (EMS) workout that is designed to enhance your fitness at every stage of life. Our FDA-cleared EMS technology works with your body rather than against it, delivering personalized and efficient strength, power, cardio,...
Suggested
Full time
Remote job
Flexible hours
...functional team including marketing, clinical, regulatory and engineering in the preparation of documents for regulatory submissions to FDA or other agencies
Negotiate site budgets and contracts
Liaison with Institutional Review Boards (IRB)
Setup and...
Suggested
Contract work
Local area
Work from home
Work visa
Flexible hours
...groundbreaking, full-body Electro-Muscle Stimulation (EMS) workout that is designed to enhance your fitness at every stage of life. Our FDA-cleared EMS technology works with your body rather than against it, delivering personalized and efficient strength, power, cardio,...
Suggested
Full time
Remote job
Flexible hours
...and basic clinical trial processes
•Knowledge of clinical trials life cycle through the different phases preferred.
•Knowledge of FDA regulations, ICH guidelines, GCP's and/or familiarity with standard preferred.
•Familiarity with research terminology or the...
Suggested
Hourly pay
Holiday work
Work experience placement
Remote job
Flexible hours
Shift work
...manipulation, pushing and pulling.
Work requires the following motions: bending, twisting, squatting and reaching.
Exposure to FDA approved cleaning chemicals.
Exposure to temperatures: 90 degrees Fahrenheit.
Ability to work in wet and dry conditions.
Ability...
Suggested
Hourly pay
Holiday work
Full time
Work experience placement
Immediate start
Flexible hours
Shift work
Night shift
All shifts
...manipulation, pushing and pulling.
work requires the following motions: bending, twisting, squatting and reaching.
exposure to fda approved cleaning chemicals.
exposure to temperatures: 90 degrees fahrenheit.
ability to work in wet and dry conditions.
ability...
Suggested
Holiday work
Full time
Work experience placement
Immediate start
Flexible hours
Shift work
Night shift
All shifts
...operations.
~ Must have a Mobile Equipment Operator Authorization card.
~ Preferences:
~ GMP environment experience.
~ Knowledge of FDA/ISO requirements.
~ Proficiency in inventory control functions.
Ready to take on this exciting opportunity? Apply now!...
Suggested
Hourly pay
Full time
Temporary work
For contractors
Day shift
Responsibilities: Expertise in GMP compliance and FDA/EMA regulations. Demonstrate excellence in written and verbal communication. Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships. Innovative, proactive, and...
Suggested
Work experience placement
Immediate start
...Discharge (ESD) type environment experience is helpful
Experience working within a rigorous, quality control environment such as FDA cGMP/QSR or ISO is a plus
Ability to work using a microscope & good manual dexterity and eyesight is required
Good communication...
Suggested
Hourly pay
Holiday work
Temporary work
Local area
Immediate start
Day shift
Afternoon shift
...to expedite the Division's research objectives. This position is also responsible for organizing and facilitating sponsor-initiated, FDA-initiated, and institution-initiated audits of study data. Finally, this position interacts with representatives from federal and state...
Suggested
Contract work
Interim role
Flexible hours
Weekend work
Afternoon shift
...glove wear
PREFERRED QUALIFICATIONS:
Associates or Bachelor’s Degree
Experience working with SOPs, GDP, GMP, CLIA, and the FDA
Experience working in a highly regulated or high-volume retail environment
Excellent interpersonal, organizational, technical,...
Minimum wage
Holiday work
Full time
Temporary work
Traineeship
Local area
Remote job
Relocation
Shift work
Afternoon shift
...glove wear
PREFERRED QUALIFICATIONS:
Associates or Bachelor’s Degree
Experience working with SOPs, GDP, GMP, CLIA, and the FDA
Experience working in a highly regulated or high-volume retail environment
Excellent interpersonal, organizational, technical,...
Minimum wage
Holiday work
Full time
Temporary work
Traineeship
Local area
Remote job
Relocation
Shift work
Afternoon shift
...Jointly responsible for performing required quality control activities as mandated by the Mammography Quality Standards Act (MQSA) and the FDA. Dependant on location, may be required to utilize general radiography skills to perform diagnostic radiology exams.
Providence...
Full time
Local area
Shift work
...GMP materials
Perform all work in adherence to our standard operating procedures and regulatory requirements such as ISO 13485 and FDA 21CFR Part 820, documenting nonconformances and suggesting improvements as needed
Provide guidance to entry-level staff
If...
Holiday work
Temporary work
Local area
Shift work
...materials within a manufacturing production environment.
Experience working within a rigorous, quality control environment such as FDA cGMP/QSR or ISO.
A strong team player with the demonstrated abilities and willingness to wear “multiple hats” , to perform a wide...
Holiday work
Temporary work
Local area
Weekend work
Weekday work
...Skills & Experience
1 year in Cosmetics / Drug Safety / Labeling
1-2 years in Compliance / Legal Compliance / Regulatory Compliance / FDA / FDA 21 CFR
2+ years of compliance program management, legal, governance, audit, risk/loss prevention, or equivalent experience...
Work experience placement
...Job Description
The Manufacturing Pharmacy Technician is responsible for compounding sterile preparations in an FDA-regulated 503b Outsourcing Facility, using aseptic technique and following Current Good Manufacturing Practices (cGMP). The technician is also responsible...
Local area
Shift work
...capital plan ensuring sound investments and optimal ROI.
Maintains plant conditions as "audit-ready" and in accordance with KPSC, FDA, USDC, third-party regulatory agencies and customer requirements.
Optimizes plant throughput (Right First Time) including yields,...
Full time
Shift work
...acids, bases, solvents, calculating moles of a substance into grams).
Learn ISO 9001 Quality Standards as they apply to the business. FDA Medical Device Class II Quality Standards may also be applicable.
Preferred Qualifications:
# Advanced Statistical methods...
Immediate start
...management principles, concepts, practices, and standards.
Proficient in current Good Manufacturing Practices and other applicable FDA, USDA and EU regulations.
Excellent written and verbal communication skills.
Solid organizational skills including attention to...
Temporary work
Relocation
Shift work
...characterization and/or commercial process support.
•Experience with scaling up unit operations with an understanding of cGMP requirements, FDA, and ICH guidelines.
•Experience in communicating and presenting complex technical information to internal and external teams.
•...
Holiday work
Remote job
Flexible hours
Night shift
...solving skills required
~ Experience IQ, OQ, PQ Validation Strategies preferred
~ Experience with notified bodies(China NMPA/ USA FDA) regulated medical device manufacturing in a Lean production environment preferred
~ Understanding a supply chain fundamentals that...
Contract work
Local area
Remote job
Work visa
...Seven or more years of product development experience, with at least five years designing electro-mechanical devices or a similar type FDA regulated medical device strongly preferred.
In-depth knowledge of mechanical tolerance analysis and Designed Experiment...
Holiday work
Contract work
...Visual Studio).
~ Experience writing and debugging test scripts Ruby preferred, other languages acceptable.
~ Experience with ISO, FDA, or other regulated product development environments strongly desired.
Skills and Abilities:
Must be able to multi-task...
Holiday work
...degree and/or equivalent combination of education and experience is required.
* 3-5 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
* Hands-on experience with batch record review...
Work experience placement
Worldwide