The Johns Hopkins School of Medicine is seeking a GXP QA Specialist II for the Oncology Center Support Services.
Specific Duties & Responsibilities
Collaborating with the Directors of the Blood Marrow Transplant (BMT) Program, Marrow Collection Facility (MCF) Cell Therapy Laboratory (CTL) Facility, and Immune Effector Cell (IEC) Program with developing goals, operational policies, and procedures.
Directing clinical, collection, and laboratory quality and regulatory activities to maintain regulatory and accreditation status.
Collecting, summarizing and evaluating quality data.
Investigating deviations and implementing preventative actions.
Other duties as assigned by the GXP QA Director or BMT/MCF/IEC/CTL Directors
Supports activities that prevent the excessive use of human resources or materials.
Seeks opportunities to assist co-workers.
Responds to requests from other departments within mutually agreed upon time frames.
Actively participates in BMT, IEC, MCF, CTL meetings and Investigator meetings.
Supports the BMT, IEC, MCF, CTL staff through training and education.
Evaluates data and uses direct observations to identify and recommend ways to improve QA and Quality Control (QC) efficiency.
Performs final review process for facility sanitization records.
Schedules and performs internal audits related to general laboratory safety and cleanliness.
Reports safety and security issues to Management.
Safety & Sanitization Activities:
Leads during external audits and in the preparation of the QA responses.
Directs the scheduling of activities related to product release timelines.
Performs product release and inventory updates to the clinical facilities.
Qualifies contract vendors for activities associated with infectious disease and product testing.
Writes documents such as study protocols, validation studies, SOPs and quality systems reports.
Performs the process of writing CMC for IND submission to the FDA.
Performs recalls that may affect supplies used in the manufacturing of cellular therapy products.
Completes final reviews and makes effective SOPs and their associated document control process.
Schedules and conducts audits of testing facilities within JHHS; testing facilities and vendors outside of JHHS.
Establishes, assigns and reviews relevant GXP SOPs.
In collaboration with the CTL Laboratory Director, approves the distribution of final products for clinical use.
Approves the rejection and destruction of materials that fail to satisfy regulatory criteria for clinical use.
Organizes and evaluates statistical quality data to generate and report quality indicators. Designs and continually improves quality related worksheets, templates, and other documents.
Investigates quality events as part of the Deviation Management process including incidents, deviations, non-conformances, OOS, then presents these findings, and provides corrective actions, to BMT, MCF, IEC and CTL Directors.
In collaboration with QA Director, develops 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.
Approves and directs 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.
Establishes 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 quality management oversight from a clinical cell therapy perspective
Performs high-level analysis of clinical patient data and outcomes together with clinical laboratory data
Bachelor's Degree in Medical Technology or other Biological Science.
Requires minimum of 4-years previous quality/regulatory experience with progressively increasing responsibility in a cell therapy, cell collection or BMT setting.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
*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.
Masters Degree preferred.
Classified Title: QA Specialist II Working Title: GXP QA Specialist II
Role/Level/Range: ACRP/04/ME Starting Salary Range: $62,780-$86,390-$110,010 Annually Commensurate with experience Employee group: Full Time Schedule: M-F 8am-4pm Exempt Status: Exempt Location: School of Medicine Campus Department name: SOM Onc Oncology Center Support Services Personnel area: School of Medicine
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines:
30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
The successful candidate(s) for this position will be subject to a pre-employment background check.
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.
If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the Talent Acquisition Office at email@example.com. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit accessibility.jhu.edu.
The following additional provisions may apply, depending on campus. Your recruiter will advise accordingly.
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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