PHARMA & BIOTECH "Quality Release" & "Clinical Data Analyst" CONSULTANTS

📢 WE'RE HIRING | PART-TIME PHARMACEUTICAL & BIOTECH QA and DATA MANAGEMENT CONSULTANTS Cascades Consulting LLC is seeking experienced Quality Assurance professionals for two exciting consulting opportunities supporting a biotechnology client. We are looking for accomplished professionals who bring deep industry expertise, work independently, and thrive in collaborative, fast-paced biotech environments. Both opportunities offer remote, part-time consulting arrangements with flexible hours and an anticipated 6 to 12-month engagement, renewable. 🔹 POSITION 1: QUALITY RELEASE MANAGER (GMP)🔹 Job ID: CC_QRM_GMP_East, Hourly Rate: $105–$130/hour – depends on experience Location: Remote Engagement: Part-time | Up to 15 hours/week | 6 months, renewable Key Responsibilities: Review executed manufacturing batch records and support batch disposition recommendations. Evaluate deviations, investigations, CAPAs, and manufacturing documentation for GMP compliance. Review pharmaceutical product complaints, investigations, and quality trends. Identify and escalate product quality, compliance, and potential regulatory concerns. Ideal Candidate: 8+ years of pharmaceutical or biotechnology Quality Assurance experience. Strong GMP background, including batch record review, disposition support, and product complaint investigations. Working knowledge of FDA 21 CFR Parts 210/211, ICH Q7/Q10, EU GMP, and data integrity requirements. Experience overseeing contract manufacturing organizations (CMOs). Experience with biologics, oncology products, or Veeva Vault preferred. 🔹 NEW! POSITION 2: CLINICAL STUDY DATA ANALYSIST (PART-TIME CONTRACTOR)🔹 Job ID: CC_CDM_VENDOR_East Hourly Rate: $42-$52/hour Location: Remote | No travel Engagement: Part-time | Up to 20 hours/week | 6 months, renewable Key Responsibilities: Small Biotech Client is seeking a highly organized, detail-oriented Clinical Study Data Analyst (Contractor) to provide sponsor-side support for clinical data review, data quality monitoring, issue management, and cross-functional study operations across assigned clinical studies. The Clinical Study Data Analyst will work closely with the Associate Director of Data Management to ensure the integrity, quality, and analysis readiness of clinical trial data. Key responsibilities include ongoing data review and cleaning, tracking and escalating data issues, facilitating timely issue resolution, and coordinating with cross-functional teams to support study milestones and deliverables. The successful candidate will take a proactive approach to identifying data discrepancies, managing follow-up activities, and helping maintain high standards of data quality throughout the clinical development process. Ideal Candidate: Education & Experience Bachelor's degree in Life Sciences, Nursing, Pharmacy, Public Health, or a related scientific discipline required. Minimum 3-5 years of experience in clinical data management, data sciences, data programming, or related functions at a pharma or biotech company. Clinical Research Associate (CRA) experience with a significant data review component may also be considered. Experience reviewing clinical trial data listings and reports. Familiarity with CRO and vendor oversight activities. Preferred Qualifications: Background as a Clinical Scientist, Clinical Data Manager, Clinical Data Reviewer, or Clinical Trial Analyst. Experience supporting oncology clinical trials. Sponsor-side clinical operations or data management experience. Working knowledge of ICH GCP and clinical trial processes. 📩 HOW TO APPLY📩 Interested and qualified professionals are invited to submit their resumes and cover letters to: [email protected]. IMPORTANT: Please include the Job ID in the subject line of your email so we can route your application appropriately. Email Subject: Application – [JOB ID] – [YOUR NAME] Candidates should have the ability to provide consulting services through an established business entity (LLC or corporation). Application Review & Selection Process We appreciate your interest in opportunities with Cascades Consulting. To ensure alignment with our client's needs, applicants should carefully review the minimum qualifications before applying. Candidates must meet the position's stated minimum requirements to be considered. All applications will be reviewed against the position's qualifications and client requirements. Due to the anticipated volume of applications, only candidates selected for further consideration will be contacted. We sincerely appreciate the time and interest of everyone who applies. We welcome referrals! If you know an experienced Quality Assurance or Clinical Data professional who may be interested, please share this opportunity with your network. Cascades Consulting LLC Connecting Expertise with Opportunity. Cascades Consulting LLC is committed to fair and equitable consideration of qualified candidates based on job-related qualifications, experience, and the requirements of each engagement. #NowHiring #CascadesConsulting #BiotechJobs #PharmaJobs #QualityAssurance #GMP #GCP #ClinicalData #ClinicalQuality #VendorOversight #QualityManagement #ConsultingOpportunities #RemoteConsulting