Manager Quality Systems and Operational Workflow
Baltimore, MD
Full Time
Mid Level
Accelevir Diagnostics is a growing Baltimore, Maryland biotechnology company creating innovative molecular and immunology assays. Our approach for detection of ultra-rare analytes includes expertise spanning virology, immunology, and genomics. Our team develops, scales, and commercializes complex assay workflows to support biopharma, academic clinical trials, and regulated testing under CLIA.
About the Role:
Our expanding Contract Assay Services Group is looking for a Manager Quality Systems and Operational Workflow. This is a unique position that includes a cross-over between performing laboratory assays for customer samples, authoring and revising SOPs, growing the Quality Systems, and leading CAP certification for the Company. This candidate will interact across functional areas to identify, review, and assist with lab investigations/deviations, root cause analyses, and CAPAs as appropriate to ensure compliance with the established Quality Management System. This role will also include oversight of training for routine lab operations such as cleaning and instrument maintenance. This role has the opportunity to expand, lead change, and interact with strategic customers engaged in Clinical Trials.
Skills:
About the Role:
Our expanding Contract Assay Services Group is looking for a Manager Quality Systems and Operational Workflow. This is a unique position that includes a cross-over between performing laboratory assays for customer samples, authoring and revising SOPs, growing the Quality Systems, and leading CAP certification for the Company. This candidate will interact across functional areas to identify, review, and assist with lab investigations/deviations, root cause analyses, and CAPAs as appropriate to ensure compliance with the established Quality Management System. This role will also include oversight of training for routine lab operations such as cleaning and instrument maintenance. This role has the opportunity to expand, lead change, and interact with strategic customers engaged in Clinical Trials.
Skills:
- Experience handling patient and/or clinical samples within a CAP/CLIA laboratory workflow
- Understanding end-to-end laboratory workflows and following strict SOPs.
- Assay validation and qualification.
- Strong knowledge of GxP, GCLP, CLIA environment and quality control processes including SOPs.
- Well versed in selected analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other/or methods for testing clinical trial samples.
- Working knowledge of quality systems and regulatory requirements (21 CFR Part 11).
- Preferred: Experience in the biotech and/or pharmaceutical industry.
- Required: Experience handling and processing clinical samples.
- Self-starter with high energy and strong work ethic.
- MS OR BS in Biology, Molecular Biology, Genetics, Biotechnology OR AA Degree.
- Candidates will have 3+ years’ experience in CLIA and biotechnology workflows.
- Technical expertise as noted in Skills is required.
- Team player who is flexible and innovative.
- Attention to detail with strong communication skills.
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