Average salary: $107,208 /yearly
More stats ...pack lines.
Key Responsibilities:
Understand and follow appropriate standard operating procedures and work instructions
Regulatory awareness of chemical handling and hazards
Labeling
Safety procedures
Department specific SOP's
Proper use and basic...
Regulatory
Hourly pay
Contract work
Temporary work
...+ Collaborate with cross-functional teams to gather requirements and implement system enhancements.
+ Ensure compliance with regulatory requirements, such as FDA regulations and Good Manufacturing Practices (GMP) guidelines, during system changes and upgrades.
+...
Regulatory
Immediate start
Remote job
Shift work
...manufacturing/production principles and techniques to critical areas of production.
* Represents company by interfacing with customers and regulatory agencies and assisting with internal and external audits.
* May act as main contact in audit.
* Develops and coordinates...
Regulatory
Holiday work
Contract work
Temporary work
Local area
Immediate start
Worldwide
Flexible hours
...investigations.
Additionally, the engineer will write technical reports in support of manufacturing process changes, optimizations, and regulatory filings. Optimizing the manufacturing process and determining root cause of manufacturing deviations are critical to ensure...
Regulatory
Permanent employment
Remote job
Shift work
...+ Provides system administration/maintenance of the data trending electronic systems.
+ Manage and support data inquiries from regulatory agencies and matrix teams using data systems (LIMS, Discoverant, Datalake)
+ Provides data and analysis for regulatory inspections...
Regulatory
Contract work
Remote job
Shift work
...potential solutions.
Ability to troubleshoot issues identified and determine root cause.
Ability to interpret and apply cGMPs, regulatory requirements, and industry best practices.
Ability to exercise judgment and makes sound decisions within generally defined...
Regulatory
Temporary work
Remote job
Shift work
...Visual experience are an advantage.
•Supporting a qualified environment such a Manufacturing Facility and experience in supporting regulatory audits/inspections.
•Ability to work collaboratively with colleagues, augmented staff, and third-party vendors.
•Ability to...
Regulatory
Local area
Remote job
Shift work
...Maintain a skills matrix for NDT technicians, ensuring all personnel remain qualified to perform work per CFS filings and state regulatory standards
Maintain a close relationship with key stakeholders, including the CFS radiation safety team, operations, and supply...
Regulatory
For subcontractor
Shift work
Night shift
Weekend work
...effectively to present ideas, facts and some technical information, and to respond to inquiries and complaints from customers or regulatory agencies.
* Ability to use standard business software applications and specialized spreadsheet and database systems (e.g. manufacturing...
Regulatory
Contract work
Temporary work
Work experience placement
Immediate start
Worldwide
Flexible hours
Shift work
Day shift
...project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
+ May represent the department in regulatory inspections (internal and external audits).
+ Train and mentor others on multiple QC test methods, processes, and procedures....
Regulatory
Remote job
Shift work
...with cGMP standards.
Responsible for contributing to audit readiness and for participating in quality audits with FDA, other Regulatory Agencies, and customers, as needed.
Carry out any other duties which are within the employee’s skills and abilities whenever reasonably...
Regulatory
Full time
For contractors
...As the Medical Device Software Quality Engineer at VulcanForms Inc., Devens, MA , you will be the subject matter expert of regulatory compliance requirements for verification, validation, and maintenance processes of non-product software. This key member of the Quality...
Regulatory
Holiday work
...the manufacturing engineering team
Qualifications
10+ years of experience in the manufacturing of complex products with regulatory requirements (automotive, aerospace, defense, medical, etc.)
Experience leading from-scratch business workflow and system integrations...
Regulatory
Hourly pay
Holiday work
...perspectives
+ Performs technical quality review for complex system or process related studies and investigations
+ Ensures that all regulatory and cGMPs compliance items related to validation are satisfied
+ Directs the oversight of change control and IT change...
Regulatory
Work experience placement
Local area
Remote job
Shift work
...effectively to present ideas, facts and some technical information, and to respond to inquiries and complaints from customers or regulatory agencies. Ability to use standard business software applications and specialized spreadsheet and database systems (e.g. manufacturing...
Regulatory
Contract work
Remote job
Flexible hours
Shift work
Day shift
Monday to Friday
...reporting.
Manage the annual external audit and ensure compliance with US Generally Accepted Accounting Principles (GAAP), applicable regulatory and governance requirements including internal policies and procedures, donor requirements, and municipal bond covenants....
Regulatory
Local area
...customers requiring special diets.
May clean and sanitize workstations and equipment and must follow all Company, client and regulatory rules and procedures.
Physical Requirements
Lift and carry up to 50 lbs.
Work in a standing position in the dining facility...
Regulatory
...platforms
~ Exposure to FDA regulated environments including validation experience
~ Understand 21 CFR Part 11, GAMP 5, and other regulatory guidance associated with computer/automation based systems
~ Previous project management experience
~ Experience with OSI PI...
Regulatory
Contract work
Remote job
...manufacturing/production principles and techniques to critical areas of production.
Represents company by interfacing with customers and regulatory agencies and assisting with internal and external audits. May act as main contact in audit. Develops and coordinates corrective...
Regulatory
Contract work
Local area
...effectively to highly sensitive issues.
+ Ability to write reports, manuals, presentations and articles using distinctive style.
+ Regulatory experience and safety knowledge (understanding of OSHA requirements)
+ Demonstrated communication, administrative and leadership...
Regulatory
Contract work
For contractors
Remote job
Shift work
...desirable.
Experience in working in an environment governed by SOP's and cGMP's and the know-how to work and manage within a regulatory oversight.
Experience in both calibration and maintenance of instrumentation on biotech manufacturing equipment bioreactors, chromatography...
Regulatory
...optimize and/or continuously improve work processes, techniques, and systems.
Manage team to ensure full compliance with applicable regulatory guidelines, internal and customer audits, EHS and Group Procurement ethical standards, policies, procedures, and processes....
Regulatory
Temporary work
Local area
...Responsible for contributing to audit readiness and for participating in Quality and EH&S audits with internal Company groups, regulatory agencies, and customers is essential.
Responsible for reporting all near misses, accidents, and dangerous occurrences through...
Regulatory
Local area
Shift work
Night shift
Weekend work
...Develops quality metrics, design and production certification plans to ensure compliance with contractual, Company, Customer and regulatory requirements.
Conducts capability assessments and process validations to support supplier selection activities.
Maintains Supplier...
Regulatory
Holiday work
Remote job
...DEA and OSHA requirements and compliance within functional areas of Supply Chain as inspection ready always.
Participates in regulatory, state, and government inspections as required.
Maintain accurate raw material and consumables inventory through cycle counts,...
Regulatory
Local area
...and department SOPs.
Ensure safe and compliant cGMP operations and maintains permanent inspection readiness. Actively supports regulatory inspections.
Interact with other teams including Process Engineering and Manufacturing Support, Engineering and Facilities,...
Regulatory
Permanent employment
Remote job
Shift work
...ARIBA to resolve accounts payable invoice issues, and other business systems (Microsoft Suite, etc.) while abiding by SOP’s and regulatory requirements. This role will collaborate closely with other professionals in Procurement, Supply Planning, Warehousing, Manufacturing...
Regulatory
Hourly pay
Full time
Contract work
Temporary work
Work experience placement
Immediate start
Remote job
Worldwide
Flexible hours
Shift work
Day shift
Monday to Friday
...and foster a positive and high-performance culture.
Global Compliance: Stay abreast of global compensation and benefits trends, regulatory changes, and industry best practices to ensure Veranova’ s total rewards programs remain competitive and compliant.
Leadership...
Regulatory
Local area
...CT Manufacturing Operations, Product Operations, Quality Assurance, Quality Control, CT Development, MSAT, Supply Chain, Finance, Regulatory, etc.)
Cell Therapy Franchise
Enterprise Level partners - Alliance Management, Business Development, IT...
Regulatory
Full time
Contract work
Temporary work
Immediate start
Remote job
Shift work
...products in compliance with Regulations of intended market territory and for guiding teams on the required deliverables to support the Regulatory status of products distributed by AngioDynamics Inc.
Essential Duties and Responsibilities
~ Under minimal supervision, acts...
Regulatory
Remote job
Contract work
Temporary work
Interim role
Immediate start