Apply on Employer Site

Curium Pharma · 1 month ago

(Contractor) Senior Quality Assurance Technician

United States

Full-time, Contract

Onsite

Mid, Senior Level

3+ years exp

Curium is the world’s largest nuclear medicine company with more than a century of industry experience. The Senior Quality Assurance Technician will perform assigned quality assurance activities to comply with applicable SOP's and cGMPs, ensuring operational compliance with regulatory agencies and guidelines.

Pharmaceutical

Responsibilities

Ensure completion of require training, work (including document review, batch release, QA on-the-floor, AQLs), and timely release of materials and batches

Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)

Responsible for the thorough and efficient review and disposition of completed batch record documentation ensuring adherence to Good Documentation Practices, cGMPs and applicable local procedures

Responsible for performing and / or overseeing performance of Quality Assurance On The Floor tasks including but not limited to performing AQL inspections, performing clearances for manufacturing areas and providing Quality input and guidance to manufacturing personnel

Responsible for with dispositioning finished product, raw materials/ components and intermediates through an all-inclusive documentation review and cross reference of electronic quality systems

Responsible with release of incoming raw materials and components per applicable local procedures. This may include support for labeling dispositioned raw materials and components with appropriate status indicator labels

Ensure a safe and quality working environment through training, awareness, and compliance to safety/Quality guidelines and SOP’s

Ensure the maintenance of department, premises and equipment

Ensure that all assigned training is carried out to competently perform assigned tasks confidently and consistently

Perform all work in compliance with site safety and radiation protection guidelines

Collaborate with other team members to ensure assigned tasks are performed in a timely manner. Must demonstrate flexibility in adjusting to changing priorities and schedules

Attend mandatory trainings as required by site regulatory requirements and management

Assist with quality investigations in order to determine root cause and applicable CAPAs

Perform other general duties associated with the position as required by supervision

Qualification

Quality AssuranceCGMP ComplianceBatch Record ReviewData EntryMicrosoft OfficeProblem SolvingCommunication SkillsTeamwork

Required

Associate Degree in life science or a related field with completion of 4 college-level life science courses required

Three or more years of relevant experience required

Experience with computer data entry required, must be proficient in use of Microsoft suite office products

Must be able to analyze causes of interpersonal conflict and resolve complex communication issues (i.e., undefined roles, objectives and information gaps)

Must be able to resolve problems, handle conflict and make effective decisions under pressure

Ability to give, receive, and analyze information, formulate work plans, prepare written materials and articulate goals and action plans

Action oriented/drives for results. Ability to multitask projects that support personal and site goals. Ability to communicate professionally, knowledgeably, and efficiently

Excellent writing and verbal communications skills

Ability to do simple to complex math calculations, input data into the computer and analyze data as required

Ability to work independently and as part of a team

Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels

Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment

Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury

Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed

May be required to sit or stand for long periods of 8+ hours a day while performing duties

Must possess good hand-eye coordination; close attention to detail is required

Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants

Willingness to complete safety training within allotted timeframes, and work in a team-based environment

Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require