This job board retrieves part of its jobs from: Toronto Jobs | Emplois Montréal | IT Jobs Canada

Liberty and Prosperity for all - new job offers every day

To post a job, login or create an account |  Post a Job


QA Compliance Specialist – CAR T

Alpha Consulting

This is a Full-time position in Summit, NJ posted April 7, 2021.

QA COMPLIANCE SPECIALIST CAR TSUMMIT, NJProject Description:The CAR T Compliance Support Specialist supports the Summit West CAR T Warehouse Operations organization, managing sustained compliance across multiple department areas and across multiple shifts.

The position is responsible for assessing process improvements and cGMP document updates, change control compliance, Deviation and CAPA management, process metrics, as well as supporting consistent communication to the department teams and staff members.

The position will also partner with Warehouse Operations supervision / management to support Quality Assurance observations and audit responses and timelines.This position plays a critical role in the CAR T warehousing processes ensuring quality is intrinsic to the operation; appropriate controls are enabled, communications to staff are consistently delivered and warehouse operations are continuously improved.

The CAR T Compliance Support Specialist interfaces with the different operations groups, collaborating with department and support functions to meet objectives and goals.

The position assures compliance with all FDA, DEA, DOT, ISBT, CTPAT, OSHA, VAWD, cGMPs and applicable policies, regulations and certifications including training, documentation, standard operating procedures and corporate policies.Responsible for the adherence and administration of all Operating Procedures, protocols, policies, regulatory requirements, GMP guidance and safety guidelines.Responsible for maintaining all required records and adherence to established guidelines for quality control procedures, GMPs, and safety.Manges and drives timely completion of department Deviations, CAPAs and Change Controls; serves as SME for Warehouse Operations for quality recordsSupports WO / SC projects and Operation Excellence initiatives.Interfaces with department Training Leads and ensures compliance for team members in training systems (i.e., Compliance Wire)Assesses and provides direction for existing and new business processes; provides SOP updates and enables training to WO staff.Ensure development, implementation and maintenance of appropriate training curricula for WO staffSupports reporting metrics, and provide information for WO KPIsManage the creation, implementation and compliance for all documentation, procedures and policiesEfficiently coordinates, communicates, and provides essential Warehouse Operations information and activities status to related functions in a timely manner in accordance to schedules and defined implementation timelinesCommunicate effectively to multi-functional and multi-location teams through team and individual settingsAct as a change agent in a fast-paced environment to promote flexibility, creativity, and accountabilityBuild a collaborative environment that fosters decisive decision making and accountabilityBuild trust and productive relationships with peers and stakeholdersDeliver business results through timely and quality decision makingFosters a culture of high ethics and compliancePromote a mindset of continuous improvement, problem-solving and preventionCreate an environment of teamwork, open communication, and a sense of urgencyDrive collaboration across the company and external partnersDevelop, maintain and actively manage relationships with support functions, customers and external partners to ensure productivity and collaborationProvide a safe and healthy work environment for staff within areas and ensure compliance with all appropriate policies and regulationsWork with CAR T Materials Management Organization to build short and long-term capacity models for all warehouse space requirements including controlled room temperature, refrigerated and freezer storageRequired Skills:Advanced knowledge cGMP warehouse operations including best industry practices, application of principles, concepts, practices, standards, validation and qualificationAdvanced knowledge of cGMP/GDP/Pharmaceutical regulationsProficient knowledge of OSHA, DEA, USP and other applicable WH regulationsProficiency in ERP systems / WMS Applications and analytics toolsProficiency in system and application use for business operationsAdvanced proficiency in MS Office applicationsAdvanced analytical, problem-solving, and critical thinking skillsAdvance project management experience handling multiple projects simultaneouslyAdvanced organizational and time management skillsStrong written and verbal communication skillsStrong presentation development and delivery skillsAbility to adapt to changing business conditions while maintaining appropriate level of controls and compliance with regulatory requirementsDemonstrated proactive, high attention to detail and follow-throughAbility to work with people at varying levels within the organization and varying skillsetsAbility to work independently and manage multiple tasks / timelinesAbility to travel 5%
– 10% of timeBachelor’s degree in supply chain, engineering, life sciences, information systems, business management or related fields.

Advanced degree preferred.10+ years relevant work experience required, preferably in a regulated pharmaceutical manufacturing environment.7+ years experience in warehousing, quality, manufacturing and supply chain areas.Direct supervisory /personnel management experience preferredUnderstanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.An equivalent combination of education, experience and training may substitute.This 6+ month position starts ASAP.Please E-MAIL your resume (attachment to email) with rate and availability to Jennifer: jennifer@alphaconsulting.comALPHA’S REQUIREMENT #21-00975MUST BE ELIGIBLE TO WORK IN THE U.S.