Title : Manager, Laboratory Compliance, Clinical Biomarker Laboratory

Location: Norwood MA (onsite)

Pay- $70 an hour

Job Description

• Issue management.
• Support and collaborate with cross-functional departments to ensure timely documentation of non-conformances, root cause analysis, and closure of QA Events
• Ensure Corrective and Preventive Actions are documented correctly and actioned in a timely manner by scientific team.
• Participate and support internal and external audits of the laboratory.
• Support development of effort to centralize document storage for electronic and hard copy documents.
• Ensure staff training records are complete and up-to-date
• Assist in the drafting of new SOP’s and/or providing review and feedback of procedures authored by the team.
• Assist scientific team to ensure laboratory and study documentation is retained correctly and prepared for archiving and in line with ALCOA+ principles.
• Compile and report on Quality metrics and make recommendations for changes to processes, procedures, and training, as applicable.

Requirements

• Minimum of 3 to 5 years of relevant experience required in regulated laboratory environment with 2 years of supervisor or management experience within drug development at pharmaceutical, biotech or CRO
• Masters/ Bachelor in a scientific discipline, such as Biology, Chemistry, or related field
• Previous experience in working in CAP/ CLIA, GLP, GCP regulated laboratory is required
• Knowledge in clinical sciences and technology is required
• Previous experience leading, reviewing, managing governance documents, access and archiving to vault highly preferred
• Attention to detail, organizational ability, clinical judgement, and good communication skills
• High proficiency in MS PowerPoint and MS Project, excellent writing skills, organizational skills, and attention to detail
• Excellent interpersonal and collaborative skills, and the ability to work independently and effectively in a highly dynamic environment