...is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. The Quality Technician supports manufacturing and servicing operations...
Suggested
For contractors
Local area
...collection, including donor set-up, donor monitoring and donor disconnect.
•In compliance with SOPs and Food & Drug Administration (FDA) guidelines, performs venipuncture on donors to begin pheresis process.
•Evaluates vein performance of the donor to identify...
Suggested
Holiday work
Full time
Temporary work
Local area
...communication/mailings to customers.
* Process/Follow-up on customer and inventory import/export orders. Coordinates regulatory issues (FDA/Customs/TSCA) as they arise in relation to import/export orders and new materials.
* Keeps Sales informed of all relevant customer...
Suggested
...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 a flexible schedule including...
Suggested
Holiday work
Part time
Flexible hours
Shift work
Night shift
Sunday
Saturday
...set up and restock.
Must have reliable transportation and the ability to report to work on time.
Knowledge of health code and FDA regulations is desired.
Prepare basic components of each dish on our menu using our proven recipes.
Memorize and utilize our serving...
Suggested
Full time
Temporary work
Part time
Local area
Shift work
...Proficiency in Microsoft Office Suite
~ Bachelor's Degree required; graduate degree preferred
~2 years of auditing experience in an FDA-regulated environment
~ Experience in a regulated industry with exposure to Quality Assurance and/or Internal Audit programs
~...
Suggested
For contractors
...releasing, and communicating changes to company supplier quality assurance policies and procedures.
Qualifications
~2 years in FDA-regulated environment with technical specs and documentation.
~ Proficient in Microsoft Windows and Office applications.
~ Excellent...
Suggested
For contractors
...supplier quality assurance policies and procedures.
~ Other duties as assigned.
Qualifications:
Two years experience in an FDA regulated environment using technical specifications and documentation desired.
Proficiency in Microsoft Windows and Office...
Suggested
Holiday work
Temporary work
Casual work
Remote job
Flexible hours
...Bachelor's Degree required and/or combination of experience
Graduate degree preferred
Two years experience auditing in an FDA-regulated environment preferred.
Experience in a regulated industry with Quality Assurance and/or Internal Audit program exposure...
Suggested
Holiday work
Temporary work
Casual work
Flexible hours
...# On a daily basis, completes and maintains the driver log and books to ensure compliance with state and federal agencies (D.O.T., FDA, and OSHA).
# Maintains communication with Branch Manager to keep aware of route status, change in order or other issues.
# Safely...
Suggested
Weekend work
Afternoon shift
...CPR) and AED certification
Fulfill state requirements (in state of licensure) for basic IV therapy
Satisfactorily complete the FDA approved training requirements for BioLife Medical Support Specialist
Two years in a clinical or hospital setting
More about...
Suggested
Hourly pay
Minimum wage
Holiday work
Full time
Temporary work
Seasonal work
Local area
Remote job
...become qualified to work in aseptic environment inside ISO 7 rooms and ISO 5 workspaces, ensuring admixtures are completed properly per FDA and cGMP requirements. The 503B Sterile Compounding Technician is also responsible for managing product inventory and supplies and is...
Suggested
...validation / qualification of aseptic pharmaceutical processes and / or equipment
· Strong understanding of Regulatory Guidance Framework FDA/EU, Industry Best Practices and cGMPs
Pay range will depend on experience.
Onsite - Monday-Friday 8am-5pm
**Holidays, 50%...
Suggested
Holiday work
Monday to Friday
...& sharing of BL resources to carry out the required compliance audits. Proactively searches literature and regulatory guidance (ICH, FDA) to maintain awareness of current regulations Builds strong relationships with suppliers. Operational Excellence Development and maintenance...
Suggested
Full time
Immediate start
Shift work
Night shift
Weekend work
...and enzymes for complex diagnosis and prognostic markers Contribute to corporate strategy for additional regulatory approvals (CAP, FDA, ) relating to GHI Histopathology Assess the quality of slide preparations and troubleshoot procedures if necessary Prepare control slides...
Suggested
Permanent employment
Full time
...departments for tasks that require qualification / validation expertise.
Adhere to Plans, SOPs and Packages ensuring regulatory compliance (FDA/EU) with industry standards, practices and trends.
Prepare Qualification / Validation Packages (Protocols and Summary Reports)...
Contract work
...0-15 years' of progressive experience in manufacturing and supply chain management is required, along with a strong understanding of FDA quality system requirements and global medical device quality standards. The role demands expertise in LEAN manufacturing, quality management...
Remote job
...scratch.
Have strong organization skills and the ability to multitask in a high pressure environment.
Knowledge of health code and FDA regulations is desired.
Uphold cleanliness standards.
Have the desire to grow, learn, and use creativity in problem solving....
Temporary work
Local area
Shift work
...CPR) and AED certification
Fulfill state requirements (in state of licensure) for basic IV therapy
Satisfactorily complete the FDA approved training requirements for BioLife Medical Support Specialist
Two years in a clinical or hospital setting
More...
Hourly pay
Minimum wage
Holiday work
Full time
Temporary work
Seasonal work
Local area
Remote job
...external departments that require qualification / validation expertise.
~Adhere to Plans and Packages ensuring regulatory compliance (FDA/EU) with industry standards, practices and trends.
~Prepare Qualification / Validation Packages
Qualifications:
~Bachelor’s...
Holiday work
...solve problems.
Excellent problem-solving skills.
Good organizational and communication skills.
Proficient with 21 CFR Part 11, FDA, and GxP requirements.
Expertise within CROs and scientific and clinical data/ terminology, and the drug development process....
...eye disorders. We participate in the development of cutting-edge technology in ophthalmology. Our doctors have been involved with many FDA studies, taking part in the research behind the intraocular lenses (IOL) that are now commonly used in vision correction.
About...
...within a clinical laboratory setting and/or gene therapy manufacturing experience, within a quality setting
Understanding of JACIE/FDA/FACT/CAP/AABB regulations and standards
Experience within inspections within clinical laboratory/and or cell and gene therapy...
...CPR) and AED certification
Fulfill state requirements (in state of licensure) for basic IV therapy
Satisfactorily complete the FDA approved training requirements for BioLife Medical Support Specialist
Two years in a clinical or hospital setting
What...
Hourly pay
Minimum wage
Holiday work
Full time
Temporary work
Seasonal work
Local area
Remote job
...essential to this position.
Must have reliable transportation and the ability to report to work on time.
Knowledge of health code and FDA regulations is desired.
Prepare basic components of each dish on our menu using our proven recipes.
Memorize and utilize our...
Full time
Temporary work
Part time
Local area
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 a wet and cold environment....
Holiday work
Full time
Flexible hours
Night shift
..., Microbiology, or Sciences, and/or equivalent experience.
~5-7 years of progressive experience within cGMP quality operations and FDA regulations.
~ Well-versed in the compliance and quality requirements of 503B pharmaceutical industry and cGMPs.
~ Familiarity with...
Hourly pay
...Mass Spectrometry experience, skill and technique. E xperience in working at an academic center doing NIH grant budgets, regulatory FDA, IRB work submissions, developing business plan for unit, etc. is highly desired.
*This designated division/laboratory specific position...
Temporary work
Work experience placement
Second job
Shift work
Day shift
...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 a wet and cold environment....
Holiday work
Full time
Part time
Flexible hours
Night shift
...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...
Holiday work
Flexible hours
Night shift