Lab Qa/qc Management
Looking for experienced qa/qc managers in laboratory setting to help understand calibration of liquid equipment handling (handheld pipettes and automated systems)+9 Other Responses
Vice President Quality
Vice president of quality: this is a full-time employment opportunity onsite in seattle washington, usa.
Responsible for oversight of the quality assurance (qa), quality control (qc), and validation departments. The vp works closely with the leadership team to develop and execute the corporate goals and objectives for the company. The position is responsible for leading the company as a clinical and commercial manufacturing organization. The vp is responsible for oversight of the site quality systems and assuring the overall gmp compliance with current regulatory requirements and guidelines.
-15+ years of experience in biotech and/or pharmaceutical manufacturing
-10+ years of experience in quality operations (qa, qc and/or validation) within biotech and/or pharmaceutical industry
-exceptional customer interface skills are required
-strong working knowledge of quality systems (fda qsit and ich q10) and how those systems are implemented to meet fda and ema requirements
-experience supporting regulatory filings (e.G., inds, blas, mms, etc) and leading product-related inspections for us and foreign regulatory agencies
-experience developing, implementing and executing strategic plans and objectives for organizations and departments.
-provide leadership and direction to the quality organization.
-serve as an active member of the site leadership team responsible for development and setting of site strategy and goals
-mentor and develop staff members within the organization.
-the vp of quality holds final accountability for and decision making on the matters relating to gmp compliance for the site.
-responsible for setting the overall strategies and directions of the qa, qc and validation departments. Decisions are focused on key strategic and operational matters that have significant, direction-setting impact on the overall company.
-responsible for setting and aligning goals and objectives for the qa, qc and validation departments with the overall corporate goals and objectives. Ensuring that the goals and objectives are accomplished. Failure to effectively execute responsibilities may negatively impact critical, company-wide goals, objectives, and outcomes. In addition, there may be legal and regulatory consequences.
-accountable for development of qa, qc and validation departmental budgets that support the corporate and departmental goals and objectives. Responsible for controlling the budget during the fiscal year.
-provides advice and counsel to the leadership team on regulatory gmp compliance issues.
-serves as the principal site spokesman with customers, regulatory agencies, etc., on matters of regulatory gmp compliance.
-requires the ability to negotiate and achieve alignment with executive management and external audiences at the highest levels, including regulatory agencies.
-works with other sites to align and integrate quality systems.
Please contact us here on zintro to learn more.+58 Other Responses
Subject: expert request opex management in plasma dna pharma product companies
hope this message finds you well! we have a new research project that may fall within your area of expertise.
We are seeking experts who could help us understand opex management in dna pharmaceutical product companies. Experts should be;
1. Knowlegable in functional areas such as maintenance, qa/qc, engineering, operations and supply chain
2. Knowlegable about the european, se asian and north american market
3. Able to speak about optimal headcount levels and staffing ratios
4. Experience in companies with revenues between 1bil and 20bil
please note that we are only looking for your expert insights from experience and are not interested in any confidential information.
I would be grateful if you could please let me know if you are available and interested to share some insight from your experience to our study or point us to particular experts you worked with who might be knowledgeable in this area?
We are looking to schedule our interviews over the next 2 weeks (including the weekend), if that would fit with your schedule. The budget on this project would allow us to provide a flexible compensation of usd 250 for a 40-45 minute call, but please do note that you will be able to discuss and agree on a compensation directly with the interviewer at the time of the interview.+6 Other Responses
We are a small company that manufactures electrical safety equipment. In addition to our products, we brand label for schneider electric. Their customers are a lot of hospitals that use 10-25kva transformers - these are mounted in steel back boxes. Unfortunately these back boxes have been coming to us with bad welds and they are not staying together. These transformers as you know are very heavy and this has become a safety concern. Since we are a small business we would like to have an experienced quality assurance associate inspect these boxes and give their opinion to schneider.+7 Other Responses
Laboratory Quality Assurance In Uae
Job title: qa director
this job post has been authorized by zintro.
- this is a responsible, professional, supervisory, and technical position in the administration of a specific department of the medical laboratory.
- the quality assurance director plans and directs the quality management system programs and practices of the lab to ensure patient safety, compliance with all local and international accreditation standards, and scientific best practices.
- the director works closely with all members and levels of the our team to ensure compliance with the aforementioned. Responsibilities are performed with considerable independence with accountability to the medical director and the chief executive officer.
**key job summary**:
- ensure the overall quality of services rendered to laboratory clients relative to reliability, accuracy, and precision.
- provide proactive leadership in the identification and rapid resolution of problem issues which adversely affect quality
- direct quality programs including the implementation of policies and systems which lead to continuous quality improvement.
- promote a culture of quality throughout the laboratory system through communication and increased quality awareness.
- direct the daily operations of the qa/qc department.
- maintain standard performance of laboratory staff and technical operations to ensure accurate and consistent testing procedures.
- train, mentor, and evaluate laboratory staff to ensure quality control, safety, and record maintenance, in coordination with technical leadership.
- ensure every laboratory is inspection-ready.
** preferred experience**:
- communicate qa programs to technical and administrative staff.
- establish standard operating procedures and safety standards
- knowledge of cap / jci / iso 15189 accreditation requirements
- international certification on quality management (preferred)
- american society of clinical pathologists (ascp) certified iso 15189 experience.
- work autonomously
**minimum qualifications and experience**:
- bsc in medical technology with appropriate clinical internship/ laboratory technology or biomedical science
- minimum of seven (7) years as a quality assurance manager/director in a college of american pathologists accredited laboratory.+3 Other Responses
Job title: quality assurance manager - manufacturing
location: west chester, pennsylvania
reports to: president
competitive salary and benefits. Relocation offered for the right candidate.
The quality assurance manager is responsible for the development and implementation of the systems that ensure that our products and processes are meeting their goals for quality and improvement, in accordance with the quality policy and iso – certified quality management system, (qms). In order to achieve these strategic goals, the qa manager will lead a team of quality assurance roving inspectors and final inspectors as well as serve as the management representative for the iso 13485 qms. The qa manager will also communicate with customers on quality and other issues to ensure that effective steps are taken to measure and improve customer satisfaction, and serve as principal contact for quality audits, surveys, and corrective actions.
this position requires strict confidentiality. Access to company information will not be discussed with anyone inside or outside the company.
- work with management to develop specific and measurable goals, improvements and standards to continuously and consistently improve quality and reduce errors.
- act on behalf of the customer to audit and maintain the accuracy and timely delivery of products.
- ensure that first article inspections, (fai’s), are performed in a timely manner throughout the day.
- make sure that roving inspections are done at all work stations on a routine daily basis and results are reported back to the machinist.
- see to it that final inspections are done in a thorough manner and in accordance with shipping requirements and scheduling.
- maintain iso 9001 and 13485 medical device quality management system certifications and compliance.
Additional details of job description available upon request.
- bs engineering or related discipline, or asq certification, or equivalent experience.
- 10+ quality experience in a precision machining environment.
- experience with implementing and maintaining iso 9000 certification.
- knowledge of statistical process control practices.
- willing to work 40 or more hours weekly.
- basic computer knowledge. Familiarity with ms word, excel and outlook.
- cnc / swiss experience
please note: we are seeking to hire a full-time employee and are not interested in responses from those only interested in consulting.+75 Other Responses
I'm look for a qc expert witness (with a background in electrical construction and government contracts)+3 Other Responses
Clinical Quality Assurance
We're looking for a clinical quality assurance auditor:
1. Gcp or gxp auditing experience in a cro, pharma, or biotech setting.
2. The ability to travel
3. General knowledge of regulations: 21 crf part 11, gcp guidelines & standards.
-flexible work schedule.
-proven potential for professional growth.
-a community of brilliant minds at your disposal.
-the stability of working for a robust, financially sound cro that is growing at a sustainable pace.
-exposure to more than 20 therapeutic areas, including cutting edge therapies such as immuno-oncology, biosimilars, gene therapy, and new molecular entities.
As a clinical quality assurance auditor you will:
-assure that processes, quality systems, and inter-location synchronization within are aligned to promote an efficient working environment that follows compliance to regulations, standards, and good gcp guidance and provides clear pathways for inquiry, reporting, and resolution through audit, the capa process, and quality metrics.
-serve as liaison for quality compliance to all locations providing oversight from a corporate level.
-write and issue audit reports and communicate audit findings to relevant project team members and/or functional area management. Administrate the controlled documentation program by reviewing, revising, and writing sops.
-identify inefficient or outdated working procedures, develop revision plans, and conduct future review to determine the success of the procedure modifications.
-travel to multiple locations to conduct internal audits. Travel to suppliers to conduct vendor qualification and assessment audits.
-bachelors degree in a science or related field.
-at least 3 years of cro or pharma related experience.
-at least 2 years of relevant gcp auditing experience in a pharma, medical device, cro, or similar environment.
-general knowledge of relevant regulations including 21 crf part 11 and gcp guidelines and standards.
-asq-cqa or similar certification desired.+33 Other Responses