Woodstock
Job Description Woodstock Sterile Solutions is driven to positively impact global healthcare by providing our partners the best quality solutions to their sterile development and commercial needs. We are a growing organization with a bright future, and we are looking for motivated and experienced team members. We offer a comprehensive benefits and a generous Paid Time Off package. This position will be scheduled to work Wednesday – Saturday, 7AM – 4:30PM. I. Position Overview: The position is responsible for testing Cleaning, Raw Material Water, In-Process and Finished Product samples. Supports laboratory investigations, system testing and process validation and business development activities. II. Specific Duties, Activities, and Responsibilities: • Completely, accurately and precisely prepares all laboratory reports and/or test scripts and documents in accordance with cGDP and cGMP requirements, • Demonstrates high ethical standards, • Maintain current training status on relevant equipment and procedures, • Comply with all cGMP, regulatory and corporate and EHS requirements, • Demonstrates ability to multi-task and prioritize work, • Maintain laboratory in audit readiness per cGDP and cGMP practices, • Perform peer review for testing and calculations, as necessary, • Recognizes Out of Specification, atypical and/or anomalous data, escalates to management, as necessary, • Maintain effectiveness of the Quality System components relevant to this position., • Identify, evaluate, and manage risk to ensure product quality. Communicate risk policies and processes throughout the organization., • Perform analytical testing and calculations on in-process bulk material, finished product, cleaning and customer samples, • Receive and prepare reagents and standards, • Air dryer testing, • Perform Calibration Checks (Balance/pH/Conductivity/Pipettes etc.), • Perform Rinse Water testing: TOC, Conductivity, • Perform Raw Material Water testing: Nitrates, • Operate analytical instrumentation, • HPLC, UV/Vis, Balances, Densitometer, Autotitrator, pH meter, Conductivity Meter, Total Organic Carbon Analyzer (TOC), Osmometer, Viscometer, Karl Fischer, Particle Counter, Malvern, Polarimeter, Microscope... (trained on NLT 11 laboratory instruments), • Perform pH adjustments, • Perform Viscosity Ostwald viscosity, • Perform Batch release testing, • Autotitrator: All products and titrant standardizations, • Wet Chemistry testing of in-process bulk material, finished product,, • Ex) TLC, Deliverable Volume, Opalescence, Degree of Coloration, • Prepare and generate reports to support Critical System Release, • Maintain analytical trending and metric tracking, • Trains other analysts in routine testing, as necessary, • Supports laboratory investigations and/or studies, as necessary, • Global TrackWise workflow for Deviations or Laboratory Investigations or Change Control, • Proficient in one of the three: Deviation or OOS/OOTr or Change Control, • Must be able to complete LIR’s, • Other duties as assigned III. Position Requirements: Education or Equivalent: • Demonstrated intermediate mathematical ability., • High level of attention to detail, well organized and multi-task oriented., • Excellent documentation skills., • Strong communication skills both written and oral., • Strong problem solving and analytical skills., • Works well in a team environment with a variety of individuals and personalities within and between departments., • Review reports, etc. for accuracy and logic., • Must be able to multitask, be proactive and willing to take initiative and responsibility., • Should be familiar with cGMP and safe work practices., • Be organized. Maintain good records and be able to access them rapidly. Understand where information can be found., • Make sound judgments. Blend knowledge and analysis with logic, active listening, and a continuing interest in simplification. Act ethically., • Ability to stand for up to 8 hours per day, • Visual Acuity (20/30 corrected vision)., • Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, writing, talking, listening, • Occasional stooping, kneeling, crouching, bending, handling, carrying, grasping, • Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 30 pounds Notice to Agency and Search Firm Representatives: Woodstock Sterile Solutions is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Woodstock Sterile Solutions employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Woodstock Sterile Solutions. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.