...Monitor sterility of self, supplies, equipment and environment as required.
Accurately complete all paperwork in accordance to FDA and other site specific procedures and policies.
Perform other related duties as required and assigned.
Education and Work Experience...
Suggested
Work experience placement
Day shift
...of 2-4 yrs. working experience in a cGMP Quality Control, analytical development, analytical transfer or validation department in an FDA-regulated industry.
Knowledge of principles, concepts, and practices in QC testing of protein biopharmaceuticals.
Hands-on...
Suggested
Contract work
Work experience placement
...Minimum of 2-4 yrs working experience in a cGMP Quality Control, analytical development, analytical transfer or validation department in a FDA-regulated industry.
•Knowledge of principles, concepts, and practices in QC testing of protein biopharmaceuticals.
•Hands-on...
Suggested
Work experience placement
...Requirements:
Minimum of 1- 3 years' relevant industry experience.
Familiar with 21 CFR Part 11, standard GxP best practices and FDA regulations.
Excellent verbal and written skills.
Good interpersonal communication skills.
High School Diploma, or...
Suggested
Contract work
Monday to Friday
...Support and train staff on GLP regulations and SOPs as needed.
Education, Experience & Skills Required:
* Working knowledge of US FDA, OECD, and ICH regulatory requirements including 21 CFR Part 58, 21 CFR Part 11, 21 CFR Part 320, and other relevant guidance and...
Suggested
Full time
Contract work
...Frontage’s clients. He she will perform all necessary tasks to generate a completed body of work ready for use in scientific publication, FDA submission, or further research and analysis by the clients. Tasks will include planning and ordering materials, drafting...
Suggested
Full time
Contract work
...Support Management and BD team for new business opportunities
* Maintain a general working knowledge of phase I-IV clinical trials, FDA regulations/ICH guidelines and other pertinent regulations.
Requirements:
* Has a B.S. degree or higher
* Has at least 2-3...
Suggested
Remote job
...facilities are USDA registered, NIH assured, AAALAC accredited, GLP & cGMP compliant, ISO certified, DEA licensed, OLAW assured, and FDA inspected. Our focus is to maintain accuracy, timelines, and reliability at every stage of development. For more information on the company...
Suggested
Contract work
Temporary work
Flexible hours
...management and communication skills and have the ability to lead a multi-disciplinary department.
• Must have solid understanding of GLP, FDA Guidance or CLIA.
• Excellent Communicator and Client-Focused.
• Regular domestic and international travel required....
Suggested
Full time
...manufacturing.
~5+ years of people management experience.
~ Experience with cGMP guidelines and regulations. Strong knowledge of FDA, EMEA & ISO regulations.
~ Strong oral and written communication and interpersonal skills. Ability to work well in a team environment...
Suggested
Full time
Contract work
...test build
Experience with LabVantage
Experience in performing or assisting clinical laboratory testing
Working knowledge of FDA GCP, CLIA Regulations, HIPAA, CAP checklists are highly desirable
High level of accountability with self and others
Hands-on...
Suggested
Full time
Contract work
...facilities are USDA registered, NIH assured, AAALAC accredited, GLP & cGMP compliant, ISO certified, DEA licensed, OLAW assured, and FDA inspected. Our focus is to maintain accuracy, timelines, and reliability at every stage of development. For more information on the company...
Suggested
Contract work
Temporary work
Local area
Work alone
Flexible hours
...Oversee Quality Control processes in the Bioanalytical Sample Management team.
Maintain knowledge regarding phase I-IV clinical trials, FDA regulations/ICH guidelines, and other pertinent regulations.
Education, Experience & Skills Required:
Bachelor’s degree or...
Suggested
Full time
Contract 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
Holiday work
Full time
Work experience placement
Immediate start
Flexible hours
Shift work
Night shift
All shifts
...Minimum of 5 years of experience in pharmacovigilance, good experience and understanding of pharmacovigilance;
Knowledgeable of FDA PV regulations and relevant global regulations and guidance for clinical and post-marketing safety;
Experience in PV management of...
Suggested
Contract work
...Ensure Frontage lab global computer system validation program meets both business and regulatory requirements. Assist with client and FDA audits as necessary.
Provide validation support for Bioanalytical, DMPK, Biologics, Clinical and IT as needed.
Leverage...
Full time
Contract work
...Agreements and work on Data Reconciliations.
6) Use StudyDoc to generate report templates and prepare Watson result tables
7) Client/FDA Audit Support
Essential Duties & Responsibilities
List below the major areas of responsibility of the job in descending...
Full time
...Ensures that personnel are properly trained and developed to meet clinical logistics needs
• Maintain a general working knowledge of FDA regulations/ICH guidelines and other pertinent regulations.
“Must Have”
• Minimum of 3 years’ experience of clinical trial test...
...Performs all mammography tracking following MQSA guidelines and requirements.
Maintains all QA documents necessary to exceed Annual FDA Inspection requirements.
Is responsible for obtaining and maintaining ACR accreditation.
Exceptional compensation for the right...
Part time
Flexible hours
Weekend work
...alignment of QC priorities with the site priorities/strategy, also ensuring strategy deployment.
Leader in the Audit Room for ISO Audits, FDA Audits, Supplier Audits, and other applicable regulatory or non-regulatory body audits.
Inspect, test, or measure raw materials used...
Local area
...Organize sample distribution/shipment
Coordinate testing at various sites for reagent qualification or requalification
Comply with FDA, EPA, DEP, DOT, OSHA, and client regulations and policies
Provide superlative service to clients by performing duties accurately...
Permanent employment
...approval for departmental documents and coordinate document approvals against timelines.
Support internal and external audits, inspections, FDA pre-inspection readiness, certifications, tracking, and trending activities.
Support the maintenance program by reviewing, approving,...
Work experience placement
Local area
...Job Responsibilities:
~Review and edit materials (including websites, slide decks, banner ads, etc.)
~Review content for style, FDA rules and regulations, syntax, spelling, accuracy, and consistency
~Assists in fact-checking and has the ability to understand scientific...
Remote job
...activities accurately and in a timely manner;
Responsible for the safekeeping of all medication stock and the records required by the DEA, FDA, and ADP;
Dedicates a minimum of 90% of regularly scheduled work hours to activities directly related to the administration of...
Part time
Local area
Shift work
Early shift
Monday to Friday
...drafts, submits and gains clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, requires working knowledge of products...
...General (OIG)
o US Department of Heath and Human Services Exclusions Database (HHS)
o US Food and Drug Administration: Debarment List (FDA)
o Global Terrorist Watch Lists (OFAC, SDN, Interpol, etc.)
Drug TesT:
12 panel w/ Fentanyl
Position Summary:...
Contract work
Freelance
Remote job
Shift work
...Experience in study management, clinical-ops, human biological sample management and related process development.
~ Knowledge of ICH GCP, FDA GCP Regulations and EU clinical trials directives.
~#LI-Hybrid
Our Benefits
CSL employees that work at least 30 hours...
Summer work
Worldwide
...Organize sample distribution/shipment
Coordinate testing at various sites for reagent qualification or requalification
Comply with FDA, EPA, DEP, DOT, OSHA, and client regulations and policies
Provide superlative service to clients by performing duties accurately...
Holiday work
Full time
Monday to Friday
...compliance with safety practices and government regulations as they pertain to the normal operating activities of the facility including FDA GMP/Quality Assurance policies and procedures
Other duties as assigned
The Candidate
~ Minimum B.S. degree with...
Holiday work
Contract work
Local area
Worldwide
...experience in IT & Quality in a regulated medical devices realm
2-3 years in software management or other IT environments subject to FDA or other government regulations.
2-3 years of hands-on experience in software validation and managing validation strategies
1+...
For contractors
Remote job