Average salary: $20,080 /yearly
More stats ...Title: Director, GMP QA
Company Overview: our client is a dynamic and innovative small molecule biotech company committed to advancing novel therapeutics to address unmet medical needs. With a focus on cutting-edge research and development, they are dedicated to...
Suggested
Worldwide
...investigator meetings
* Coordinate clinical site audit activities including pre-inspection training at clinical sites in partnership with QA
* Establish systems for tracking of various activities during clinical trials, e.g., accruals/invoices, tracking of clinical...
Suggested
Full time
Contract work
...and learn while you put your skills to work.
Experience Required for Your Success
Requirement:
~2-4 years of experience in IT QA related experience
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work...
Suggested
...Operations, Clinical Development, Clinical Supply Chain, Medical Affairs, Regulatory, Legal, and other teams across Alumis.
The Clinical QA Director is responsible to ensure quality is embedded throughout the lifecycle of all the ongoing clinical programs through oversight...
Suggested
...resolve issues and mitigate risks.
Responsibilities
Support managing a risk-based clinical Quality Management System (QMS) for GCP QA in compliance with applicable regulatory requirements (US and OUS), and company policies.
Author and review Standard Operating...
Suggested
Full time
Contract work
Flexible hours
...the development of and ensures compliance with the clinical monitoring plan; co-monitors as needed for training and quality assurance (QA) purposes.
* Contributes to the case report form (CRF) design process including content, form layout, and edit check review.
*...
Suggested
Full time
...qualification of process equipment. In addition, the candidate will interface with Manufacturing, Process Science, Facilities, Validation, QA, and Contract Engineering/vendor firms to produce detailed designs for procurement, construction, installation, start-up, and...
Suggested
Contract work
...product specifications, develop comparability strategies, and support manufacturing investigations
Collaborate with Manufacturing, QA, and Process Development teams to evaluate and investigate issues
What we're looking for
PhD in Cell Biology, Molecular Biology...
Suggested
Holiday work
Temporary work
Work experience placement
Immediate start
...clinical trials. The Sr. CTM/CTM will also work cross-functionally with other groups such as Clinical Development, CMC/Supply Chain, QA, Regulatory Affairs and Project Management to ensure study team goals are met.
Principal Responsibilities
•Support study leader...
Suggested
Apprenticeship
Local area
...Kitchen waste and waste discharge.
- Maintains good communication with studio Departments, i.e., Enrober, Shipping, Human Resources, QA, Payroll, etc.
- Participates, implements and provides leadership to the Sees Safety, GMP, QWC programs; enforces Sees Rules and...
Suggested
Holiday work
Contract work
Flexible hours
Shift work
Night shift
Saturday
...Functions
Support the PharmDev teams to ensure uninterrupted clinical supply.
Collaborate closely and effectively with CMC, RA, and QA leadership, and team members, to execute the internal and external supply strategies.
Ensure development projects achieve key...
Suggested
Remote job
...initiate workflows in the electronic data management system
Track documentation workflow progression within other functional areas and QA, providing routine updates and reminders, and escalating as required
Provide status reports and quality metrics to support the...
Suggested
Temporary work
Local area
Flexible hours
...improvement processes;
•Direct the training of new and existing employees on food safety and quality programs;
•Alternate cover: QA Manager.
•Provide coverage during production runs on extended shifts and weekends, when needed.
•Additional Q.A. duties as...
Suggested
Hourly pay
Work alone
Shift work
Weekend work
...implement SOPs and guidelines related to the production, planning, disposition and management, materials, etc.
Works with Regulatory, QA and Management to ensure that all company policies are adhered to, and all external manufacturing activities comply with relevant...
Suggested
Contract work
For contractors
Apprenticeship
Local area
...Lead activities in support of acquisition, integrations including configurations, conversions, and change management.
Perform QA testing of new features to ensure that requirements are met, and the resulting user experience is as intended.
Lead and support user...
Suggested
Worldwide
Relocation bonus
...approve as necessary revisions to manufacturing cGMP and non GMP documentation.
* Where necessary, provide input to manufacturer and QA for evaluation of process deviations and assist in the investigation of product complaints
* Support the design, implementation,...
Contract work
...with data integrity.
Represent Quality on project teams, Health Authority Inspections, suppliers and CMO operational meetings, and QA to QA meetings.
Promote a quality mindset and quality excellence approach throughout the organization.
Education & Experience...
Contract work
...well as external vendors/3rd parties. Provide training and support for inspections at sites, CROs and service providers.
Serve as QA representative on clinical study development teams; participate in the review and approval of clinical trial “essential documents” (e...
Full time
...to data management activities
Co-lead vendor and technology evaluation, qualification, and selection
Work closely with IT and QA to ensure that system infrastructure meet Biometrics needs and industry regulations and best practices.
Define requirements for collection...
Full time
Contract work
Temporary work
...appropriate statistical methods, and compile the data into reports and presentations.
Collaborate with cross-functional teams (CMC teams, QA, Regulatory, and CMOs/CTLs) to drive Alumis projects forward to meet project timelines.
Write and/or review analytical documents,...
Contract work
...position is full-time, direct hire, onsite, salary range $130K - $155K.
Responsibilities:
Implement and manage project-specific QA/QC Programs.
Review and approve trade contractor QA/QC Programs to ensure alignment with general contractor and client program...
Full time
For contractors
...existing quality procedure workflows, identifies areas of improvement for efficiency and compliance.
Acts as an Analytical QA subject matter expert in support of regulatory inspections and internal audits.
As a quality functional site lead at CTLs, supports...
Contract work
Hakimo is a seed-stage startup whose mission is to modernize physical security operations using AI and modern software. Funded by top Silicon Valley VC firms, Hakimos software has been deployed at multiple top enterprises across the world.
Were looking for a Quality...
...as the need arises
Follow up on audit related CAPAs, SCARs and communicate results back to suppliers and/or customers
Conduct QA reviews on quality & compliance guidelines that are implemented and followed across Benchlings internal SDLC and GxP impacting business...
Summer holiday
Local area
Remote job
Home office
Flexible hours
We're working with a better-for-you meat processor looking to identify a driven QA Director to join their SQF facility in Northern California. My client is primarily retail but is expanding into foodservice as they continue to grow.
The QA Director acts as the liaison...
...acting as a liaison and facilitator of cross functional teams (i.e., Clinical Development, Clinical Operations, CMC, Tox, Regulatory, QA, Finance, BD, Marketing, etc.) in planning and executing trials.
Performs effective risk management assessments with the Program...
Full time
Work experience placement
Afternoon shift
3 days per week
...strategy, including labeling and packaging design in compliance with relevant SOPs, polices, and regulations
· Works closely with QA to ensure compliance around IP documentation, procedures, Lot numbers, managing expiration dates, and coordinating release schedules....
Full time
Remote job
Flexible hours
Shift work
...essential.
Testing experience required:
Testing methodologies
Best practices
Right aptitude and interest in improving QA function
Attention to detail
Business process and workflow documentation - focused on Asset management
Test...
...in accordance with ICH/FDA/EMA/USP/Ph. Eur. guidelines.
Address review comments on QC/analytical documents in collaboration with QA and other departments.
Manage document creations and reviews via Veeva Document System.
Initiate and manage change controls, deviations...
Contract work
Interim role
...with data integrity.
Represent Quality on project teams, Health Authority Inspections, suppliers and CMO operational meetings, and QA to QA meetings.
Promote a quality mindset and quality excellence approach throughout the organization.
Education & Experience...
Contract work
Work experience placement