The QC/Production Associate I will operate the radiosynthesizers for the production of drug product, as well as operate analytical equipment for the quality control of drug product.
ResponsibilitiesPerform FDG and NaF synthesis according to Standard Operating Procedures (SOPs).Ensure all materials/reagents are accepted according to SOPs and within expiry.Ensure all equipment is appropriately qualified prior to use.Operate the synthesis unit according to SOPs.Learn the basic operational principles of the synthesis unit and assist in routine maintenance.Perform FDG and NaF quality control (QC) processes according to SOPs.Assist with basic maintenance of QC equipment.Ensure all equipment is appropriately calibrated and qualified prior to use.Operate the QC equipment according to SOPs.Ensure completion of applicable cGMP documentation.Assist with inventory management, including maintaining production/QC/cleaning supply levels, inventory reporting, and material acceptance according to SOPs.Communicate with local and network support resources to troubleshoot equipment, production, or QC issues.Perform basic computer-controlled cyclotron operations for FDG and NaF production under the advisement of the site Cyclotron and Facility Engineer.Maintain a clean and safe working environment.Perform radiation safety duties according to Corporate Radiation Compliance Program and site licensing requirements.Maintain all qualification and validation requirements for entering ISO classified areas.Clean classified and non-classified areas according to SOPs.Perform environmental monitoring of classified areas according to SOPs.Report manufacturing metrics into data repository as required.Open change controls and initiate, maintain, and review network and site-specific procedures relative to job functions.Complete cGMP documents as required and assist site and corporate Quality Assurance with investigations, corrective and preventative actions, deviations, out of specifications, no or atypical yields, and manufacturing and QC documentation.Attend internal meetings as required.Perform other assigned duties as needed.Essential SkillsBS in a related field preferred.Technical experience with computer-controlled automation preferred.Proficiency in the use of MS Office Suite required.Ability to work various shifts and weekends required.Detail-oriented, accountable, patient, organized, and able to work in a team environment required.Ability to communicate professionally with colleagues and customers.Excellent attention to detail.Dependable and responsible in a fast-paced, highly technical environment.Ability to lift 50 lbs.Up to 5% travel required.Additional Skills & QualificationsExperience in chemistry, production, GMP, laboratory, cleanroom, quality control, and HPLC.Work Environment
This position operates in a laboratory environment. Shift times could be from 12 AM to 3 AM.
Pay and BenefitsThe pay range for this position is $54080.00 - $62400.00
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Albany,NY.
Application Deadline
This position will be accepting applications until Dec 31, 2024.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
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