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Compliance Officer / Analyst
Memphis, TN
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Compliance Specialist Siri Healthcare Memphis, TN Job Details Contract $25 - $32 an hour 21 hours ago Qualifications Computer operation Teamwork Biotechnology Attention to detail Associate's degree
Full Job Description Compliance Specialist Location:
Memphis, TN 38118
Schedule:
Monday-Friday, 8:00 AM-5:00
PM Pay Rate:
$25-$32/hour
Interview:
Virtual Duration:
Approximately 4.5 months with a possible extension
Hours:
40 hours/week About the Role We are seeking a QA Technical Writer/ Compliance Specialist to support a cell and gene therapy manufacturing site in Memphis, TN. Reporting to the Manager of Compliance, this position will be responsible for creating, managing, reviewing, and maintaining technical and quality documentation within a regulated biotechnology/pharmaceutical environment. The ideal candidate will have strong technical writing and documentation skills, excellent attention to detail, and experience working with quality systems such as Deviations, CAPAs, and Change Controls . Key Responsibilities Create and facilitate the completion of quality system documentation, including Deviations, CAPAs, and Change Controls . Ensure documentation is clear, concise, accurate, and aligned with company standards and regulatory requirements. Complete routine and non-routine documentation assignments within established timelines. Work with cross-functional stakeholders to gather information and ensure documentation is complete and accurate. Facilitate document reviews and approvals and incorporate feedback from stakeholders and clients. Write, edit, and review technical documents, including SOPs, batch records, technical reports, and related documentation . Communicate results, issues, and concerns clearly both verbally and in writing. Build and maintain effective working relationships with internal stakeholders and clients. Identify opportunities to improve documentation processes, templates, clarity, efficiency, and compliance. Support and lead training activities for internal teams and functional departments as applicable. Perform other duties as assigned. Qualifications Associate's degree or higher in Life Sciences, Biotechnology, Biochemistry, or a related field preferred. 2-6 years of technical writing experience within the biotechnology or pharmaceutical industry. Experience with quality documentation and regulated environments strongly preferred. Experience in cell and gene therapy is preferred. Excellent technical writing, editing, proofreading, and communication skills. Strong attention to detail and ability to manage multiple documentation assignments. Ability to interpret and communicate complex scientific information clearly and concisely. Proficiency with Microsoft Office Suite and document management systems. Strong organizational and project management skills. Excellent interpersonal and collaboration skills. Critical-thinking ability and a proactive approach to solving documentation and compliance challenges. Work Environment & Physical Requirements Ability to sit and/or walk for extended periods. Ability to lift, push, or pull up to 10 lbs. routinely and 20 lbs. occasionally . Ability to stand, bend, and reach overhead occasionally. Ability to move between multiple office and facility locations as needed. Ability to use a keyboard, computer monitor, and other equipment requiring adequate visual acuity.
Pay:
$25.00 - $32.00 per hour Expected hours: 40.0 per week Application Question(s): Do you have Associate's degree or higher in Life Sciences, Biotechnology, Biochemistry, or a related field? Do you have experience in cell and gene therapy?
Experience:
Technical writing (biotechnology or pharmaceutical): 2 years (Required) Shift availability: Day Shift (Required)