The Oncology Department is seeking a GXP QA Specialist who works under the direction of the GXP QA Specialist II and/or the QA Director to perform responsibilities that include 1) clinical, collection, and laboratory quality and regulatory activities to maintain regulatory and accreditation status; (2) collect, summarize and evaluate quality data; and (3) investigations of deviations and recommending preventative actions.
Specific Duties & Responsibilities:
Quality Assurance Activities:
Implements the appropriate GXP QA systems to support the BMT, IEC, MCF, and CTL including, but not limited to document management and materials control, equipment and facility validation/calibration documentation, personnel training, product testing & clinical product release.
Implements product release including, review of production related documentation (Batch Production Records/Reagent Production Records/log sheets/testing records/reports, Quality Systems reports, etc.; and Issuance of Certificates of Analysis and Conformance for products satisfying regulatory criteria for clinical use.
Participates in process improvement initiatives for the Programs and Facilities by working towards constant compliance with regulatory requirements (Inspection Readiness) and ensuring policies that support the regulations are available and current.
Performs the investigation of quality events as part of the Deviation Management process including incidents, deviations, non-conformances, CAPA and OOS, and following up with BMT, MCF, IEC and CTL Management.
Organizes and evaluates statistical quality data to generate and report quality indicators. Assists with designing and improving Quality related worksheets, templates, and other documents.
Implements the rejection and destruction of materials that fail to satisfy regulatory criteria for clinical use.
Coordinates the distribution of final product for clinical use.
Participates in establishing, assigning and reviewing relevant GXP SOPs.
Investigates deviations and recommends preventative actions.
Conducts audits of testing facilities within JHHS; testing facilities and vendors outside of JHHS.
Makes SOPs and their associated document control process effective.
Monitors recalls that may affect supplies used in the manufacturing of cellular therapy products.
Participates in the process of writing CMC for IND submission to the FDA.
Participates in writing documents such as study protocols, validation studies, SOPs and quality systems reports.
Interacts with contract vendors for activities associated with infectious disease and product testing.
Participates in product release and inventory updates to the clinical facilities.
Participates in the scheduling of activities related to product release timelines.
Participates in external audits and in the preparation of the QA responses.
Safety & Sanitization Activities:
Reports safety and security issues to Management.
Performs internal audits related to general laboratory safety and cleanliness.
Participates in the review process for facility sanitization records.
Evaluates data and uses direct observations to identify and recommend ways to improve QA and Quality Control (QC) efficiency.
Supports the BMT, IEC, MCF, CTL staff through training and education.
Actively participates in BMT, IEC, MCF, CTL meetings and Investigator meetings.
Responds to requests from other departments within mutually agreed upon time frames.
Seeks opportunities to assist co-workers.
Supports activities that prevent the excessive use of human resources or materials.
Other duties as assigned by the QA Manager or QA Director.
Equipment, Machine, or Tool Requirements:
Responsible for ensuring the quality monitoring of equipment utilized by the collection facility and the cellular therapy laboratory, which includes but isn't limited to annual PM and calibrations of refrigerators, freezers, incubators, centrifuges, microscopes, biological safety cabinets, automated cell counters (SYSMEX), cell processing devices (COBE 2991), particle counters, power supplies, bioreactors (WAVE), and LN2 storage devices.
Must be familiar with proper procedures for disinfecting equipment after use and documentation of such activities.
Minimum Qualifications (Mandatory):
Bachelor's Degree in a Biologic Science
Requires a minimum of 2 years previous quality/regulatory experience or progressive clinical lab experience with progressively increasing responsibility in an academic or industry GXP setting.
* Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
Licensure, Certification, Registration:
ASCP certification for Medical Technology is preferred, but not required.
Certification from a recognized organization for regulatory affairs professionals in the healthcare and pharmaceutical fields is desirable.
Special Knowledge, Skills, or Abilities:
Highly motivated, well organized and detail oriented person with a background in the biological sciences.
Ability to critically review experimental data and analyze scientific testing reports to determine if the results meet established specifications.
Good verbal and written communication skills.
Good time management skills with the ability to multi-task.
Must be able to work mostly independently and when circumstances require it, function as part of a team encompassing individuals with diverse scientific backgrounds.
Requires flexibility for working with rapidly changing schedules, employee and interdepartmental issues
Requires knowledge of current FDA, FACT, and CAP regulations and/or standards and possesses the ability to interpret and apply these to maintain the BMT/IEC/MCF/CTL's accreditation status.
Work requires interpersonal skills, at a level sufficient to present lectures for training and continuing educational programs and effectively interact with all levels of clinical and nonclinical staff.
Comfortable performing mathematical calculations commonly used in freshman chemistry or biology courses (i.e. utilizing scientific notation, percentages, concentrations, averaging, rounding numbers, etc.).
Working knowledge of Microsoft Office.
Requires the ability to develop computer databases and spreadsheets for BMT Program information management. Requires the ability to enter and retrieve data from computer data bases and spreadsheets.
Requires the ability to evaluate deviations, perform root cause evaluations and suggest possible corrective actions. Requires good analytical reasoning and the ability to perform complex mathematical calculations. Serves as a resource to other employees. Reviews collection and processing results for variances from normal patterns.
Machines, Tools, Equipment:
Some familiarity with software applications utilized to capture and extract data, operation principles of laboratory and apheresis equipment, as well as bone marrow harvesting techniques.
Work frequently produces high level of mental/visual strain due to extensive use of computers.
Primarily office setting with some work in laboratories and patient floors.
Some exposure to contaminated materials, infectious specimens, and communicable diseases, but potential for personal injury or harm is limited if proper safety and health precautions are followed.
Classified Title: QA Specialist Working Title: GXP QA Specialist Role/Level/Range: ACRP/04/MD Starting Salary Range: $54,080-$74,390-$94,710/Annually (Commensurate with Experience Employee group: Full Time Schedule: M-F 8am-4pm Exempt Status: Non-Exempt Location: School of Medicine Campus Department name: SOM Onc Oncology Center Support Services Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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