Quality Assurance Specialist Allentown PA at Msccn

ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.Lets do this! Lets change the world!This onsite position provides critical support for the Raw Material Center (RMC) warehouse based in Easton Pennsylvania. The RMC represents an advanced logistics solution designed to optimize the raw material network serve additional manufacturing sites and facilitate inventory pooling and bulk purchasing. RMC services encompass direct supplier receipt incoming quality inspection and sampling environmental monitoring storage and transportation.Responsibilities:Ensure that all operations align with relevant regulations and Amgen requirements including Safety Good Manufacturing Practices (GMP) Good Distribution Practices (GDP) and Good Documentation PracticesConduct sampling and inspection of incoming raw materials assess documentation and determine dispositionReview documentation associated with receipt storage and distributionApprove GMP processes procedures documents and records addressing deviations CAPAs change controls risk assessments and validation records as requiredPerform routine Quality Assurance assessments and provide direct operational oversightOffer leadership guidance mentorship and training to staff and partner organizationsManage oversight of logistic and transportation service providersProvide expert advice on quality matters to operational teams and cross-functional groupsEnsure staff complete necessary training related to Amgen business operationsAchieve established metric targets and develop standardized approaches for tracking progressCollaborate with Logistic Service Providers (LSPs) to maintain service levels and identify areas for performance enhancementParticipate in quarterly business and quality reviews and address any service failures with LSPsPresent updates on LSP Quality Management System health and initiatives at management reviewsRepresent the Quality Unit during audits and inspections directly interacting with regulatory agenciesSupport internal and external audits and inspections as a member of the audit/inspection teamImplement business continuity plans for services and processesForm strategic partnerships with internal customers and external vendors to ensure operational successIntegrate risk management strategies into overall supply chain managementLead initiatives programs and projects targeting operational improvementsDevelop solutions that are comprehensive practical and align with functional goalsPerform additional duties as assigned by managementAdditional Qualifications/ResponsibilitiesWe are all different yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.Basic Qualifications:Doctorate degree ORMasters degree and 2 years of quality assurance experience ORBachelors degree and 4 years of quality assurance experience ORAssociates degree and 8 years of quality assurance experience ORHigh school diploma / GED and 10 years of quality assurance experiencePreferred Qualifications:Proven ability to communicate effectively with cross-functional teams and diverse cultures both verbally and in writingAcademic background in Life Sciences Physical Sciences Applied Engineering or Manufacturing TechnologiesPrior experience overseeing QA in distribution warehousing manufacturing validation and engineering functionsExpertise in managing deviations change controls and CAPAsProficiency in Veeva SM LIMS and ERP systemsKnowledge of industry standards (GMP GDP Import/Export)Commitment to exemplifying Amgens core valuesDemonstrated self-leadership and motivationStrong critical thinking skillsAbility to evaluate compliance issues and engage with regulatory inspectorsExperience managing multiple priorities within a dynamic environmentDirect experience with drug substances and/or drug productsAdvanced problem-solving abilities and capacity for scientific risk-based decision-makingTrack record of representing an organization during regulatory interactionsHigh proficiency in Microsoft Excel Word and PowerPointWhat you can expect from usAs we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities that may include:A comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions group medical dental and vision coverage life and disability insurance and flexible spending accountsA discretionary annual bonus program or for field sales representatives a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.Required Experience:IC Key Skills Invoicing,Information Technology Sales,IT Support,Audio Visual,Database Administration Employment Type : Full Time Experience: years Vacancy: 1