Overview
Lab Assistant Jobs in Bismarck, ND at CHI St Alexius Bismarck
Company Description
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description
Responsibilities:
Proactively investigating, identifying, and implementing best-in-class quality engineering practices.
Providing focused quality engineering support and assuming responsibility for timely and effective coordination and execution of assigned development project activities.
Establishing effective corrective action plans and leading in implementing quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
Acting as an effective leader or team member in supporting quality disciplines, decisions, and practices.
Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Reviewing and approving product and process qualifications, validations, and other change control-related documentation.
Developing product/process assurance plans, which include all required elements, and identifying and implementing effective process control systems to support the development, qualification, and ongoing manufacturing of products.
Generating internal quality documentation such as quality plans, standard operating procedures, and inspection procedures.
Participating in product review boards, identifying non-conformance trends, and developing technical investigation plans, including investigating and analyzing customer/internal complaints.
Performing analytical measurements and experiments to qualify or resolve product and process issues.
Developing and implementing strategic quality plans, master validation plans, validation protocols, inspection plans, and quality/regulatory compliance operating procedures to meet FDA and ISO requirements.
Tracking quality trends and initiating action items to resolve issues while managing assigned corrective actions.
Monitoring field quality and analyzing field returns to determine root causes.
Providing training and support for quality system processes and quality engineering practices.
Requirements:
A bachelor’s degree (minimum) in engineering, life sciences, or a related field.
3 to 10 years of progressively responsible experience in medical device quality assurance.
One to two years of auditing experience is preferred.
Certification as a CQA, CQE, or CQM and membership with ASQ are highly desirable.
Advanced computer skills to efficiently utilize quality systems and tools.
Strong writing, mathematical, and statistical skills for data-driven decision-making.
Adept at managing multiple projects and meeting deadlines with precision.
Proficient in verbal and written communication to effectively convey complex information.
Additional Information
All your information will be kept confidential according to EEO guidelines.
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Title: Lab Assistant
Company: CHI St Alexius Bismarck
Location: Bismarck, ND
