Blackwomenintech
Specialist, Quality
Blackwomenintech, Rahway, New Jersey, us, 07065
Job DescriptionOur Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interlinking global manufacturing network
dedicated
to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.As part of our Company's Quality Operations Organization, the Durham site Quality team is seeking a highly motivated individual for the Quality Operations Potency Laboratory. This position is accountable for performing lot release testing in compliance with standard operating procedures, safety, and cGMP regulations. Primary duties of this position will focus on the daily quality control lab operations.ResponsibilitiesSupport routine release testingComplete appropriate documentation supporting testing procedures, including data capture forms, equipment logbooks, and inventory formsEnter data evaluated for compliance to specifications and report abnormalitiesMaintain lab areas and equipment to GMP standards including routine cleaning and decontamination of lab benches, biosafety cabinets, and other equipmentParticipate in equipment and instrument installation, operation, and performance qualificationMaintain current training on all assigned procedures to include read & comprehend, skills development and classroom training activities as requiredMaintain close communication and interaction with QC management and staff to ensure on-time completion of assigned activitiesComply with company health and safety procedures and practicesAuthor SOPs and technical documentsOther duties as neededEducation RequirementBachelor of Science in Biochemistry, Biological Sciences, Chemistry or related fieldExperience and SkillsRequiredMinimum two (2) years in a cGMP environment in the pharmaceutical industryDemonstrated technical writing ability; able to author protocols and reportsDemonstrated structured problem-solving skills; able to drive investigational support activities to remediate method-related investigations and performance issuesDirect experience in authoring and review/approval of SOPsStrategic and effective organizational, analytical, and communications skillsFlexible and able to manage multiple assigned tasksDemonstrated time management, organizational and prioritization skillsAttention to details and good documentation skillFunction in a fast-paced team environment to meet critical production timelinesPreferredQuality Control laboratory settingsKnowledge of Laboratory systems (GLIMS, SAP)NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.U.S. Hybrid Work ModelEffective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day.Employee Status:
RegularRelocation:
NoVISA Sponsorship:
NoTravel Requirements:
10%Shift:
1st - DayJob Posting End Date:
10/3/2024
#J-18808-Ljbffr
dedicated
to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.As part of our Company's Quality Operations Organization, the Durham site Quality team is seeking a highly motivated individual for the Quality Operations Potency Laboratory. This position is accountable for performing lot release testing in compliance with standard operating procedures, safety, and cGMP regulations. Primary duties of this position will focus on the daily quality control lab operations.ResponsibilitiesSupport routine release testingComplete appropriate documentation supporting testing procedures, including data capture forms, equipment logbooks, and inventory formsEnter data evaluated for compliance to specifications and report abnormalitiesMaintain lab areas and equipment to GMP standards including routine cleaning and decontamination of lab benches, biosafety cabinets, and other equipmentParticipate in equipment and instrument installation, operation, and performance qualificationMaintain current training on all assigned procedures to include read & comprehend, skills development and classroom training activities as requiredMaintain close communication and interaction with QC management and staff to ensure on-time completion of assigned activitiesComply with company health and safety procedures and practicesAuthor SOPs and technical documentsOther duties as neededEducation RequirementBachelor of Science in Biochemistry, Biological Sciences, Chemistry or related fieldExperience and SkillsRequiredMinimum two (2) years in a cGMP environment in the pharmaceutical industryDemonstrated technical writing ability; able to author protocols and reportsDemonstrated structured problem-solving skills; able to drive investigational support activities to remediate method-related investigations and performance issuesDirect experience in authoring and review/approval of SOPsStrategic and effective organizational, analytical, and communications skillsFlexible and able to manage multiple assigned tasksDemonstrated time management, organizational and prioritization skillsAttention to details and good documentation skillFunction in a fast-paced team environment to meet critical production timelinesPreferredQuality Control laboratory settingsKnowledge of Laboratory systems (GLIMS, SAP)NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.U.S. Hybrid Work ModelEffective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day.Employee Status:
RegularRelocation:
NoVISA Sponsorship:
NoTravel Requirements:
10%Shift:
1st - DayJob Posting End Date:
10/3/2024
#J-18808-Ljbffr