Sterility Assurance Assessment Lead
3 weeks ago
Job Title:
Sterility Assurance Assessment Lead
Location:
Lexington, MA
(Hybrid - Onsite 3 days a week, 2 days from home)
Job Description:
Execution of a Current State GAP Assessment of the Contamination Control Program of the client from a Global and site-specific perspective.
Delivery of Current State Contamination Control Findings Report
Execution of microbial and/or cross contamination LOPA, HACCP &/or FMEA in identifying and assigning risk (RPN) of identified GAPs to define prioritization in overall CAPA Plan.
Delivery of Corrective and Preventive Action Plan based upon risk to remediate GAPs identified in Assessment.
Management and oversight of defined CAPA Plan with assigned Stakeholders at site; to drive delivery and promptly elevate concerns and/or roadblocks.
Required Qualifications:
Signification experience (7+ years) supporting site compliance to the global microbial/viral control standards/procedures on environmental monitoring, critical utilities, contamination control strategy, cleanroom management, microbiological methods and validations including RMM, sterilization and aseptic processing controls, disinfectant efficacy studies and microbial risk assessments.
Significant experience (7+ years) in a microbial contamination control role within the pharmaceutical or biotechnology industry.
Signification demonstrated experience in development and delivery of risk based CAPA plans.
Knowledge of cGMP/ICH/FDA/EU compliance regulations and USP, EP and JP monographs for microbiology
Strong knowledge of microbiological and sterility testing (i.e. environmental monitoring, clean room qualification and management, quality control endotoxin testing and microbiological control strategy)
Experience with oversight of aseptic processing and the associated international aseptic processing regulations.
Experience with microbiological risk assessments and prioritization techniques (LOPA, HACCP &/or FMEA)
Comprehensive knowledge of global GMP and biologic regulatory requirements
Excellent oral and written communication skills with strong technical writing experience required.
Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across corporate functions and multiple stakeholders to drive delivery of CAPA plans.
Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward.
#J-18808-Ljbffr
-
Sterility Assurance Assessment Lead
1 month ago
Lexington, United States Synergy Solutions Full timeInitial 10 month contract with possible extension/conversion to permanent employment 3 days onsite per week in Lexington MA **Support Duration**: Phase 1 GAP Assessment Execution Phase 2 CAPA Plan Delivery & Management **Primary Duties Responsibilities**: - Execution of a Current State GAP Assessment of the Contamination Control Program of the client...
-
Biomedical Technician
3 days ago
Lexington, United States Medical Application Repair & Sales Full timeJob DescriptionJob DescriptionSalary: We are seeking a highly skilled and certified Biomedical Technician to join our dynamic team, specializing in the service and repair of sterilizers and anesthesia machines. The ideal candidate will have extensive experience with equipment from leading manufacturers such as Mindray, GE, Primus, Steris, Getinge, and...
-
IT Risk Assessment Auditor
4 weeks ago
Lexington, United States MIT Lincoln Laboratory Full timeThe Security Services Department’s overall mission is to identify and counter security threats to the MIT Lincoln Laboratory’s mission of development of game-changing technology in support of National Security, including guarding against compromise by foreign intelligence agencies and insider threats. To accomplish this mission, this department...
-
Senior Quality Assurance Specialist
2 weeks ago
Lexington, United States T2 Biosystems Full timeSenior Quality Assurance SpecialistDepartment: Quality Assurance Employment Type: Full Time Location: Lexington, MA Reporting To: David Tessein Description We are seeking a collaborative and detail-oriented individual to join our team as a Sr. Quality Assurance Specialist. The position reports directly to the Manager, Quality Assurance. The ideal candidate...
-
Intake & Assessment Supervisor
1 month ago
Lexington, United States ABHS Full timeJob DescriptionJob DescriptionJob Title: Intake and Assessment SupervisorBase: Harmony Bay WellnessDirect Report: Director of Integrated ServicesJob Purpose Summary:Overview of Intake and Assessment Supervisor job functions which include clinical and administrative oversight of licensed Intake and Assessment Clinicians:1. Direct Supervision of...
-
Senior Quality Assurance Specialist
1 month ago
Lexington, United States T2 Biosystems Full timeJob DescriptionJob DescriptionDescriptionWe are seeking a collaborative and detail-oriented individual to join our team as a Sr. Quality Assurance Specialist. The position reports directly to the Manager, Quality Assurance.The ideal candidate will be someone that enjoys working as part of a fast paced, cross-functional team, balancing multiple tasks, and...
-
Quality Assurance Engineer
2 weeks ago
Lexington, United States T2 Biosystems Full timeWe are seeking a bright, energetic and detail-oriented individual to join our team as a Quality Assurance Engineer. This is an exciting role that will serve as the primary quality partner for our instrument manufacturing operations and is responsible for promoting product quality and quality system compliance across those areas. The position reports directly...
-
Senior Quality Assurance Engineer
3 weeks ago
Lexington, United States T2 Biosystems Full timeJob DescriptionJob DescriptionDescriptionWe are seeking a bright, energetic and detail-oriented individual to join our team as a Senior Quality Assurance Engineer. This is an exciting role that will serve as the quality partner for our engineering and instrument manufacturing teams and will be responsible for promoting product quality and quality system...
-
Service Line Lead Technologist/UKHC
5 days ago
Lexington, United States University of Kentucky Full timePosting DetailsPosting Details Job Title Service Line Lead Technologist/UKHC Requisition Number NR12133 Working Title Perioperative Services, Lead Technologist: Laser Department Name H3320:Perioperative Services Work Location Lexington, KY Grade Level 11 Salary Range $26.00-45.70/hour Type of Position Staff Position Time Status Full-Time Required...
-
Service Line Lead Technologist/UKHC
6 days ago
Lexington, Kentucky, United States University of Kentucky Full timePosting DetailsPosting Details Job Title Service Line Lead Technologist/UKHC Requisition Number NR12133 Working Title Perioperative Services, Lead Technologist: Laser Department Name H3320:Perioperative Services Work Location Lexington, KY Grade Level 11 Salary Range $ /hour Type of Position Staff Position Time Status Full-Time Required Education...
-
Service Line Lead Technologist/UKHC
6 days ago
Lexington, Kentucky, United States University of Kentucky Full timePosting DetailsPosting Details Job Title Service Line Lead Technologist/UKHC Requisition Number NR12130 Working Title Perioperative Services, Lead Technologist Pediatrics: ENT/Plastics Department Name H3320:Perioperative Services Work Location Lexington, KY Grade Level 11 Salary Range $ /hour Type of Position Staff Position Time Status Full-Time ...
-
Director, Pharmacy
4 days ago
Lexington, United States Baptist Health Full timeJob Description:Directs, coordinates and controls overall operations in the hospital pharmacy in accordance with accepted hospital policies and procedures, ethical and professional practices, and state and federal requirements. Directs and coordinates the integration of department functions with other aspects of overall patient care.Directs and controls the...
-
IV Technician
2 weeks ago
Lexington, United States Topaz HR Advisory Full timeJob DescriptionJob DescriptionIV TechnicianOur client a premier Long Term Care Pharmacy located in Lexington, KY is seeking an IV Technician! We offer a competitive salary!RESPONSIBILITIES:Complete IV order entry and refills into a computer system for Staff Pharmacist review.Generate accurate labels for dispensing.Analyze and resolve clients IV complaints...
-
Preschool Lead Teacher
7 days ago
Lexington, United States Communities United, Inc. Full timePreschool Lead Teacher – 40 hours, Full time, Lexington Creative StartAre you looking to join a team of supportive professionals who are invested in each other's success? Do you want to be part of an agency that has helped improve the lives of the children and families it has served for over 50 years? Communities United, Inc. offers generous paid time...
-
Computer Science
1 month ago
Lexington, United States KCTCS Full timeComputer Science (LEAD) Tutor Lexington, KY Temporary Part-time Bluegrass Community & Technical College Add to favorites Favorited View favorites Title: Computer Science (LEAD) Tutor Salary Range: $16 per hour Contract Term Length: Not Applicable Standard Hours: Varies Work Location: On-Site FLSA Status: Non-Exempt ...
-
Computer Science
4 days ago
Lexington, United States Kentucky Community and Technical College System Full timeComputer Science (LEAD) Tutor Job no: 493299 Work type: Part-time Location: Lexington, KY Categories: Temporary Title: Computer Science (LEAD) Tutor Salary Range: $16 per hour Contract Term Length: Not Applicable Standard Hours: Varies Work Location: On-Site FLSA Status: Non-Exempt College: Bluegrass Community & Technical College Campus Location: Bluegrass...
-
Director of Nursing
3 weeks ago
Lexington, United States Cambridge Place Full timeWe provide medical masks and PPE to all employees to help protect our residents, staff and their families DIRECTOR OF NURSING This position is responsible for directing and supervising the clinical operations within the facility. QUALIFICATIONS: * Graduate from accredited school of nursing. * Registered Nurse in good standing with licensure board *...
-
Validation Specialist
2 weeks ago
Lexington, United States a Medical Device Equipment located in near Lexington, MA Full timeJob Duties : Manage start-up, commissioning, qualification, validation, and revalidation projects for various processes including facility, equipment, critical utility, automation/computer systems, cleaning, sterilization, medical devices, and drug product manufacturing. Oversee the delivery of validation in complex, capital projects, ensuring adherence to...
-
Manager of Manufacturing
4 weeks ago
Lexington, United States Kindeva Drug Delivery Full timeJob DetailsJob LocationCompany Headquarters - Lexington, KYPosition TypeFull TimeJob CategoryManufacturingDescriptionSummary: In thishands-onposition, theincumbentis responsible for managing the Manufacturing Operations team during the process of manufacturing products, performing scale-up and validation activities and preparing for commercial launch of...
-
Lead Math Instructor
1 week ago
Lexington, United States Mathnasium (ID: 5200701) Full timeJob DescriptionJob DescriptionWho We Are:Across North America and all over the world, Mathnasium Learning Centers are committed to teaching children math so that they understand it, master it, and love it.Our world-class curriculum is built upon the Mathnasium Method the result of decades of hands-on instruction and development and has changed the lives of...