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ClinForce is currently searching for a QA Associate with 2-5 years experience working in a Pharmaceutical Manufacturing Facility. Ideal candidates will have a BA/BS, QA and supplier compliance or Auditing experience. For more details, please contact Busy Kimball - firstname.lastname@example.org or check out www.clinforce.com
Tags for this job: "QA", "Quality Assurance", Quality, "Quality Control", supplier, compliance, auditing
DOCS is looking for individuals with a QC background working with raw materials as well as data review experience for a new opportunity. Candidates must have worked in a GMP environmnet at a pharmaceutical or biotech company and have USP and EP experience. Knowledge of analytical methods, testing, raw materials and method validation is required. For more details, please contact Busy Kimball – Elizabeth.email@example.com or check out www.clinforce.com
Tags for this job: QC, "data review", Quality Control, Quality, Raw Materials
Overview of the role: •Annotate CRFs in accordance with CDISC published or sponsor specific guidelines with appropriate metadata to reflect case report tabulation data sets •Create and program data sets and data programming specifications per specified study requirements. Validate data sets. •Create and maintain study documentation as required •Execute programs and generate clinical data outputs according to study/client requirements •Review and quality assure CRF annotations produced by other programmers •Review and quality assure data set and programming specific...
Tags for this job: CDISC, clinical data, CRFs
REGIONAL MONITORS SUMMARY: Clinical Research Associates needed for study close-out responsibilities in Southern California DUTIES & RESPONSIBILITIES: * Chart & document review * General close-out duties * Communicate with site staff * Reporting * Other duties, as required QUALIFICATIONS & REQUIREMENTS: * 5+ years of experience in clinical research * 2+ years of CRA experience as a regional monitor * Strong understanding of monitoring procedures for clinical trials * Good communication and interpersonal skills * Neurology experience is a plus * Assoc...
Tags for this job: CRA,Regional CRA, Sr. CRA, Clinical Research Associate, Clinical Research, Pharmaceuticals, Biotech, Science, NIH, research, regional monitor, Neurology, CNS, Stroke
Process complaints which may include: o Collect necessary complaint information o Determine reportability of a complaint and submit associated MedWatch reports within 30 days per regulations o Evaluate complaint for need to investigate and coordinate sample retrieval o Document investigation and sample evaluation results o Respond to customer complaints (written or verbal) o Timely closure of complaints, as per procedure o Manage workflow; identify and escalate issues Qualifications: •Knowledge of FDA Quality System and Medical Device Reporting regula...
Tags for this job: medical device complaint