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Diatherix - Production Specialist

Hudsonalpha Institute For Biotechnology

Diatherix - Production Specialist

Huntsville, AL
Full Time
Paid
  • Responsibilities

    Diatherix - Production Specialist .extra-padding-top { margin-top: 20px; } 02-Jan-2019 to 03-Feb-2019 (CST) Huntsville, AL, USA Full Time Diatherix We offer a competitive benefits package. Production Specialist This position is with Diatherix Eurofins Clinical Diagnostics which is located in the Hudson Alpha Institute, Huntsville, Alabama. Diatherix Eurofins Clinical Diagnostics is a highly-specialized laboratory providing cutting-edge molecular diagnostic testing services to hospitals and physicians using proprietary TEM-PCR (Target Enriched Multiplex Polymerase Chain Reaction) technology for precise detection of infectious diseases at high levels of sensitivity and specificity, and at very short turnaround times. General Description: The Production Specialist is responsible for preparation of buffers and PCR reagents, documentation of reagent preparations, reacting to results of reagent QC testing, maintaining the production inventory, assisting in the revision of production documents and ordering reagents and supplies for the GMP Production laboratory. Specialists also assist in product batch records, cost analysis, Production metrics, developing a weekly task schedule and preparation of monthly charge reports. Qualifications: Bachelor's degree in chemistry or biology with 2+ years with biotech manufacturing experience preferably in GMP and GLP environment. Clean room environment experience preferred but not required. Specific Job Functions: 1. Reagent Preparation: Assist the Supervisor in the planning and scheduling of the preparation of reagents for clinical laboratory Familiarity with manufacturing of molecular grade buffer and reagents. Must have knowledge and experience with the use of pipettes, pH meters, stir plates, weighing and measuring in an aseptic laboratory environment. Nucleic acid extractions Aliquoting using micro pipettes Prepares and documents preparation of reagents. Ensures that reagent preparations performed according to approved procedures. Complies with Quality systems for reporting deviations. Assist the Production Supervisor with preparation of the Production department section of product batch records. Reagent preparation activities include: new oligo dilution preparation and aliquot primer mix preparation including supplementations controls preparation Nucleic Acid extractions proficiency testing sample preparation complex buffer preparation plasmids, bacterial cultivation and preparation bead mix coupling Other reagent preparations as requested by the Production Supervisor. 2. Inventory Control: Maintains the CisPro inventory for the Production laboratory and reconciles it with physical inventory. Submits a weekly order requisition to the Production Supervisor for approval, then to the Purchasing Manager. 3. Other: Oversees the reagent order fulfillment for on-site departments as well as regional laboratory sites. Ensures received raw materials and supplies meet required standards. Prepares SOPs and work instructions related to Production department Participates in staff meetings to discuss progress and scheduling. Prepare monthly reagent charge reports for the clinical labs and send it to Production Supervisor for review. Assessment and incorporation of secondary raw material vendors. Prepares and packages product shipments. Cleaning and autoclaving of glassware and buffer carboys. Occasionally would be required to assist with patient sample sorting in the Clinical lab. Performs other duties as requested by the Production Manager. 4. Must be proficient using a computer and have experience and knowledge with Microsoft Office Suit. Diatherix is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law. HudsonAlpha Institute for Biotechnology

  • Industry
    Government Administration