samples, clinical materials and raw material release in a c GMP regulated environment Major Responsibilities: Execution of microbiological tests including but not limited to bioburden, LAL, growth promotion, sterility, particulate profiling and microbial identification of bulk, raw materials, in-process material, components, clinical materials and finished product Review and data entry for testing results following GMP regulations into the electronic data management systems Perform laboratory investigations for out of specification and/or out of trend results in conjunction with management Write change controls and work orders for systems and instrumentation changes Creation/Revision of SOP's,
and other documents required to support testing and ensure compliance Participate in non-routine projects, validations and method development to meet departmental and individual goals The employee will be required to participate in an on call schedule for various shift, holiday, or weekend work as needed.
Preferred Qualifications: Experience with the execution of test methods for sterile and non-sterile drug products, raw materials, components and in-process testing. This includes the methods described in USP Chapters 61, 62, 71, 85, 788 and relevant informational chapters Critical thinker, ability to identify issues and work quickly to bring resolution Capable of managing/coordinating
multiple priorities in a dynamic environment, while maintaining a professional demeanor Understand common microbiological test instrumentation Excellent organizational, planning and scheduling skills Good verbal and written communication skills Experience of Thermo Sample Manager LIMS or other applicable LIMS systems The successful employee will have the ability to function in a microbiological laboratory environment; the employee should have no inhibitions regarding safely handling microorganisms present in the laboratory, aseptic gowning, and no health conditions that would prevent them from doing so Preferred Technical Abilities and Personal Skills Ability to work safely; seek out and encourage safe practices Ability to focus attention to details and ensure high quality work Ability to cope with a rapidly changing work environment Self-starter that takes initiative to do work with minimal supervision Time management skills Other Preferred Characteristics Commitment to teamwork Commitment to continuous improvement Effective communication with co-workers and supervisors Education and Experience: Bachelor's in science, preferably in Biology / Microbiology / Biotechnology or Biochemistry, required For QC Analyst III role, 3+ year experience in medical manufacturing or contract testing laboratory required Physical Requirements: This job requires a large amount of physical activity Walking, lifting, pushing and pulling carts, reaching, climbing, and bending are all required Steel toe shoes, scrubs, safety glasses, and other PPE equipment must be worn based on job being performed#Onsite#LI-RS1PDN-9ad5ba86-8c6d-4bfa-aea1-be805f2f2258
compare with records, such as manifests, invoices, or orders, to verify accuracy of incoming or outgoing Prepare documents, bills of lading, and shipping orders to route Determine shipping method for materials, using knowledge of shipping procedures, routes, and Record shipment data, such as weight, charges, space availability, and damages and discrepancies, for reporting, accounting, and recordkeeping purposes.
Contact carrier representative to make arrangements and to issue instructions for shipping and delivery of Confer and correspond with establishment representatives to rectify problems, such as damages, shortages, and nonconformance to specifications. Requisition and store shipping
materials and supplies to maintain inventory of Research for best freight Verifies that invoices from carrier match what the customer was Assist office and production departments in optimizing orders for fabrication, as Performs other assignments as POSITION QUALIFICATIONS: Competency Statement(s) Accuracy - Ability to perform work accurately and Customer Oriented - Ability to take care of the customers' needs while following company Detail Oriented - Ability to pay attention to the minute details of a project or Ethical - Ability to demonstrate conduct conforming to a set of values and accepted Organized - Possessing the trait of being organized or following a systematic method of performing
a Problem Solving - Ability to find a solution for or to deal proactively with work-related Time Management - Ability to utilize the available time to organize and complete work within given SKILLS & ABILITIES: Education: High School Graduate or General Education Degree (GED): Required Experience: 6 plus months of experience Computer Skills: Detailed knowledge of MS Office, Excel, Outlook and Power Point.
Experience with JD Edwards. PHYSICAL DEMANDS: N (Not Applicable) Activity is not applicable to this position. O (Occasionally) Position requires this activity up to 33% of the time (0 - 2.5+ hrs/day) F (Frequently) Position requires this activity from 33% - 66% of the time (2.5 - 5.5+ hrs/day) C (Constantly) Position requires this activity more than 66% of the time (5.5+ hrs/day) Physical Demands Lift/Carry Stand O21-50 lbs OWalk OSit O Push/Pull Manually Manipulate O26-40 lbs OReach Outward OReach Above Shoulder OClimb NCrawl NSquat or Kneel NBend OOther Physical Requirements: Vision (Near, Distance, Color, Peripheral, Depth) Sense of Sound Sense of Smell Sense of Taste Sense of Touch Ability to wear Personal Protective Equipment (PPE) - (Safety glasses) WORK ENVIRONMENT: Typical office work environment; frequently sitting at a desk or workstation using a computer, keyboard and mouse.
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