...a cross-functional / matrix environment.
Strong oral and written communication skills.
Ability to follow and interpret cGMPs, FDA, DEA, OSHA and ISO regulations and guidelines.
Working knowledge of personal computers and Microsoft Office Products, including Word...
Suggested
Remote job
3 days per week
...maintained and/or calibrated
Designs, develops, manages, and completes instrument and automation projects as required
Ensures FDA, cGMP compliance for all metrology and automation related records
Qualifications
Education/Experience
Bachelor's...
Suggested
...operations in compliance with company guidelines and public regulations in a manner which promotessafety (i.e. GMP, AIB, OSHA, HACCP, FDA, USDA).
•Identify deviations and document/communicate them in compliance with Standard Operating Procedures.
•Execute other tasks...
Suggested
Work experience placement
Remote job
Relocation
...action completion. Manage and document customer complaint reports using SAP electronic system. Ensures that complaint investigations meet FDA MDR requirements. Provides subject matter expertise during external audits and support to customer call center technicians Expected...
Suggested
Local area
Immediate start
...bounds/loading and unloading trucks. High reach picking full pallets and putting product away.
-Attention to detail, dealing with FDA regulated products
- Quality is much more important that quantity
- Need to be able to pick up mistakes, ensure GMP/SOPs are followed...
Suggested
Holiday work
Contract work
Summer work
Shift work
Night shift
Sunday
Day shift
Saturday
...empty and dispose of garbage.
•Work in accordance with all relevant requirements including, but not limited to GMP, AIB, OSHA, HACCP, FDA, USDA and internal safety guidelines
•May prepare raw materials for production/processing.
•Identify deviations and document/...
Suggested
Remote job
...Standard Operating Procedures (SOPs), work instructions, department policies and protocols, applicable to pertinent regulations from ISO, FDA, and other regulatory agencies.
•Review and critique the Quality Assurance program to ensure its components such as training,...
Suggested
...synthesize and communicate complex information. Capacity to propose practical mitigation (de-risking) strategies.
Strong knowledge of FDA, EMA, and ICH guidance documents and GLP regulations.
Required experience in authoring non-clinical elements of major regulatory...
Suggested
For contractors
Flexible hours
...inbound and out bounds/loading and unloading trucks. Picking full pallets and putting product away.
-Attention to detail, dealing with FDA regulated products
- Quality is much more important that quantity
- Need to be able to pick up mistakes, ensure GMP/SOPs are...
Suggested
Holiday work
Contract work
Summer work
Shift work
Saturday
...interpretation of R&D studies under the guidance of senior chemists.
Adhere to policies, processes, and SOPs to ensure compliance with cGMP, FDA and any other regulatory regulations and standards.
Adhere to set safety standards.
~ Other duties as assigned....
Suggested
Internship
...owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators.
Its core strength lies in a highly qualified global workforce of more than 400 employees across...
Suggested
Contract work
...blood center or regulated industry
Responsibilities:
Review policies and procedures and ensure that they are in compliance with FDA, AABB, and other regulations.
Review events in the Quality Management System.
Perform QA review on validations.
Write SOPs....
Suggested
Trial period
Flexible hours
Monday to Friday
...owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators.
Its core strength lies in a highly qualified global workforce of more than 400 employees across...
Suggested
Afternoon shift
...and RCCP prefered
5. Leadership Development Experience
6. Knowledge of Microsoft Office: Word, Excel & Access
7. Knowledge of FDA or GMP/GLP regulations for medical or pharmaceutical equipment preferred.
**Skills**
STERIS is a leading provider of products and...
Suggested
Price work
For contractors
Local area
...blood center or regulated industry
Responsibilities:
Review policies and procedures and ensure that they are in compliance with FDA, AABB, and other regulations.
Review events in the Quality Management System.
Perform QA review on validations.
Write SOPs....
Suggested
Full time
Trial period
Flexible hours
Monday to Friday
...increasing overall client satisfaction.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Develop policies and processes to enable compliance with FDA and all competent authority regulations and requirements.
Identify and drive initiatives in support of fostering a Quality culture...
Local area
Flexible hours
...Products tailored to Health Care, K-12 Education, Elderly Feeding, Day Care Centers and Prisons
All juices are packed to USDA and FDA Grade A Standards
Stable and Essential Employment focused on safety
National Company that accommodates relocation
Development...
Weekly pay
Holiday work
Full time
For contractors
Relocation
Shift work
Weekend work
Monday to Friday
$18 - $20 per hour
...inbound and out bounds/ loading and unloading trucks. Picking full pallets and putting product away.
-Attention to detail, dealing with FDA regulated products
- Quality is much more important that quantity
- Need to be able to pick up mistakes, ensure GMP/SOPs are followed...
Contract work
Night shift
Sunday
Day shift
Saturday
...Products tailored to Health Care, K-12 Education, Elderly Feeding, Day Care Centers and Prisons
All juices are packed to USDA and FDA Grade A Standards
Stable and Essential Employment focused on safety
National Company that accommodates relocation
Development...
Weekly pay
Full time
Relocation
Shift work
Night shift
Weekend work
Day shift
Afternoon shift
All shifts
Monday to Friday
...Manage plant HACCP program and CCP's list.
Assist with Validation New Equipment Qualification Protocols (NEQP).
Have knowledge of FDA requirements (21 CFR) for food/drug safety.
Updates job knowledge by studying trends in and developments in quality management,...
Temporary work
Local area
All shifts
...Products tailored to Health Care, K-12 Education, Elderly Feeding, Day Care Centers and Prisons
All juices are packed to USDA and FDA Grade A Standards
Stable and Essential Employment focused on safety
National Company that accommodates relocation
Development...
Weekly pay
Holiday work
Full time
Relocation
Shift work
Night shift
Weekend work
Monday to Friday
...Products tailored to Health Care, K-12 Education, Elderly Feeding, Day Care Centers and Prisons
All juices are packed to USDA and FDA Grade A Standards
Stable and Essential Employment focused on safety
National Company that accommodates relocation
Development...
Weekly pay
Holiday work
Full time
Relocation
Shift work
Night shift
Day shift
Afternoon shift
...Compliance – Knowledge of Anti-kickback laws, false claims act, foreign-corrupt practices act, Physician Payments Sunshine Act, HIPAA, and FDA regulations
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee...
Full time
Contract work
For contractors
...spend, and other litigation related metrics
Provides other litigation support as requested
Must comply with applicable ISO and FDA regulations as stated in Quality Manual
Must embody the Company’s Vision, Mission and Values
Expertise: Qualifications -...
Full time
For contractors
...Products tailored to Health Care, K-12 Education, Elderly Feeding, Day Care Centers and Prisons
All juices are packed to USDA and FDA Grade A Standards
Stable and Essential Employment focused on safety
National Company that can accommodate relocation
Development...
Weekly pay
Holiday work
Full time
Relocation
Shift work
Night shift
Weekend work
Day shift
Afternoon shift
Monday to Friday
...a member of the global B. Braun group of companies.
Responsibilities: Essential Duties
Provide legal guidance regarding FDA regulations relating to medical device and pharmaceutical product submissions; regulatory strategy and pre-market applications, including...
Remote job
Full time
Contract work
$145k - $223.2k
...oversight activities for analysis of clinical trial data, ensuring quality and timeliness; prepare deliverables for regulatory submission to FDA/EMA/PMDA or other agencies (e.g. eCRTs, ISS, ISE, BIMO, P21 checks) and provide support for regulatory questions; perform statistical...
Full time
Remote job
$78.12 - $130.21 per hour
...understanding and track record in dealing with international regulations and policies setting processes of major regulatory agencies (e.g. US FDA, EU, PMDA, NMPA, WHO).
Actively engaged in major industry associations (e.g. CPC, EFPIA, BIO, PhRMA, CASSS, PDA, ISPE, DIA) and...
Minimum wage
Holiday work
Full time
Temporary work
Local area
Remote job
Worldwide
$133.2k - $223.2k
...in compliance with Health Authority requirements; Provide regulatory assessments for change controls for various markets such as US FDA, EMA, Health Canada as well as liase with in-country regulatory representative to provide the assessments. Up to 20% remote work allowed...
Full time
Remote job
...supplies.
Complies with hospital and department policies and procedures. Completes assigned education modules. Helps maintain MSQA/FDA/ACR compliance, assists with quality control evaluation and/or performance improvement.
Minimum Qualifications
Specialized...
Shift work