Manager-Quality Assurance Stemina Biomarker Discovery
THIS JOB HAS EXPIRED Company Description
Stemina Biomarker Discovery is a growing company that uses pioneering cell-based assays which
arise from the strategic convergence of the groundbreaking technologies of metabolomics and
human embryonic stem cells. Stemina is additionally developing a diagnostic platform utilizing
metabolomics and human patient samples to understand the metabolic mechanisms involved in
health and disease. Stemina discovers and validates biomarkers for high throughput diagnostics,
drug screening, and toxicology testing in human systems. Metabolomics enables the discovery of
small molecules that can be used as therapeutic agents or candidate biomarkers of pharmacological
efficacy or toxicity. For example, the human embryonic stem cell metabolome provides a source of
candidate biomarkers to predict, diagnose or measure the progress of disease or toxic response.
Stemina provides drug screening, drug discovery and diagnostic development services for the
government as well as pharmaceutical and biotechnology companies under service contracts or joint
discovery agreements using its proprietary metabolomics platform. In addition, Stemina has
interest in using mass spectrometry based metabolomics to identify biomarkers for a number of
diseases including cancer, autism and others.
Stemina is seeking a Manager of Quality Assurance to develop, implement, monitor and maintain a
quality system that ensures Stemina will deliver on projects with integrity, validity, and overall
quality. The role includes assuring the company is using its quality program for continual
improvement of its processes and procedures. In addition, the individual will lead programs to
ensure Stemina practices and procedures comply with national and international standards as set
forth by regulatory agencies. The ideal candidate should demonstrate the ability to understand and
implement quality systems and be able to implement a training system for new employees. As a
growing company, the role is currently a part-time position; however growth of the company over
the next 12 months is expected to warrant this role becoming a full-time position.
Essential Job Duties and Responsibilities
? Build, maintain, and continually improve the Stemina Quality Management Plan as well as
Quality Assurance plans for launched product platforms.
? Serve as Stemina?s lead point of contact for all activities related to the Quality
Management Plan and Quality Assurance Plans including auditing of internal facilities and
? Have a demonstrated track record of leading quality initiatives
? Understand and implement systems to track and trend data for CAPA
? Assure that all Quality System SOP?s and revisions are complete and that the staff is well
trained at all times.
? Provide an ongoing framework and keep updated the process of SOP generation making
sure it is being used well across the organization.
Job Title: Manager-Quality Assurance Job Code: 01-13
Location: Madison, WI
Reports To: Chief Executive Officer FLSA Status: Exempt
Stemina Biomarker Discovery Direct Reports: N/A Page 2 of 2
? Work closely with biologists and analytical chemists to arrive at parameters for validation
of metabolomic data sets.
? Implement and manage a document control system, vendor qualification program, and
employee training system.
? Coordinate the archival of all paper and electronic data.
? Host regulatory inspections.
? Establish procedures for software validation and equipment qualification protocols and
change control documents.
To perform this job successfully, an individual must be able to perform each essential duty
satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or
ability required. Reasonable accommodations may be made to enable individuals with disabilities to
perform the essential functions.
Education and Experience:
? Bachelor?s degree or greater in a chemistry or biology related discipline with a minimum of 5
years of experience in a regulated quality environment, managerial experience a plus.
? A demonstrated capability of championing a quality management system as well as
implement of quality assurance programs for complex workflows.
? A strong knowledge of the guidelines for quality as used in GLP or GMP environments.
Particular knowledge of NIH or EPA guidelines is a plus.
? An understanding of chromatography, general analytical methods of analysis, and data
manipulation is expected.
Knowledge, Skills and Abilities Required:
? Effective interpersonal, verbal and written communication skills, including public-speaking
and presentation skills.
? Ability to maintain high level of confidentiality.
? Ability to effectively communicate with all levels of the organization.
? Demonstrated ability to work well independently as well as a part of a diverse team.
? Demonstrated ability to work well under pressure and manage multiple tasks with constantly
? Demonstrated ability to troubleshoot problems and recommend actions.
? Advanced analytical, organizational, and record-keeping skills.
? Willingness to travel.
? Proficient computer skills: knowledge of multiple platforms and operating systems, including
MS Office Suite. and experience with document versioning, tracking and archiving
||9201 Bear Claw Way |
Madison, WI 53717
THIS JOB HAS EXPIRED