Analytical Lab Operations Specialist II

Position Summary The Analytical Lab Operations Specialist II will be responsible for supporting lab operations within the Quality Control and Analytical Development laboratories. This includes management of materials, equipment, third party vendors, budget, documents, and quality events. This position is based on site in Durham, NC and will report to the Lab Operations Manager. Job Responsibilities Perform tasks associated with maintaining GMP-compliant quality control, analytical development, and stability laboratories as it pertains to sample management, equipment maintenance, material inventory, and other general lab operations needs Perform sample management tasks (shipment, receipt, storage) in accordance with applicable regulatory requirements and Standard Operating Procedures (SOPs) Schedule equipment maintenance and repair activities and capture documentation of services in the Computer Maintenance Management System (CMMS) in accordance with applicable regulatory requirements and Standard Operating Procedures (SOPs) Support management and execution of Operational and Capital Expenditure budgets for Quality Control and Analytical Development Labs Support initiation, review, and maintenance of contracts related to Quality Control and Analytical Development lab operations with Legal and IP departments in accordance with applicable regulatory requirements and Standard Operating Procedures (SOPs) Act as Single Point of Contact with Third Party vendors, Project Managers, Material Depots and Producers, Material Shippers, and Analytical Development Project Leads to coordinate shipment and receipt of samples and other lab reagents and materials Own, initiate, and author deviations, CAPAs, and Change Controls related to all GMP operations and processes Author new SOPs and revise existing SOPs as needed Support continuous improvement of lab operations procedures by independently identifying process gaps Participate in data review processes to ensure accuracy and completeness of information Interact with regulatory agencies as the subject matter expert for lab operations related inquiries, including sample management, equipment management and maintenance, and reagent and consumable inventory management Strictly adhere to all applicable written SOPs, company policies, and technical guidance documents, both internal and external Minimum Requirements Bachelor’s degree and minimum 2 years of relevant industry experience Experience in regulated GMP laboratory within the pharmaceutical or biotech industry Experience independently owning and authoring GMP quality events (i.e. deviations, CAPAs, change controls, etc.) Strong technical writing skills Ability to handle multiple projects/teams simultaneously Ability to work independently in a fast-paced, highly interactive environment with minimal supervision Excellent verbal and written communication skills Ability to build open and collaborative relationships and work effectively as a member of a multi-disciplinary team Excellent self-organization skills with ability to envisage/design/implement organizational systems to improve efficiency and function of working teams Preferred Education, Experience And Skills Experience and familiarity with LabVantage LIMS Experience with CMMS for equipment maintenance and management AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job-related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at View phone number on click.appcast.io or sending us an email at View email address on click.appcast.io. Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency. #J-18808-Ljbffr AskBio Inc.