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Description:

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.

Essential Duties and Responsibilities

. Perform FDG and NaF synthesis according to SOFIE Standard Operating Procedures (SOPs):

o Ensure all materials/reagents are accepted according to SOPs and within expiry

o Ensure all equipment is appropriately qualified prior to use

o Operate the synthesis unit according to SOPs

o Learn the basic operational principles of the synthesis unit and assist in routine maintenance of the synthesis unit

. Perform FDG and NaF quality control (QC) processes according to SOPs:

o Assist with basic maintenance of QC equipment

o Ensure all equipment is appropriately calibrated and qualified prior to use

o Operate the QC equipment according to SOPs

. Ensure completion of applicable cGMP documentation.

. Assist with inventory management:

o Maintain production/QC/cleaning supply levels as appropriate

o Assist with inventory reporting

o Perform 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 site Cyclotron and Facility Engineer.

. Maintain a clean and safe working environment.

. Perform radiation safety duties according to SOFIE’s Corporate Radiation Compliance Program and site licensing requirements.

. Maintain all qualification and validation requirements for entering ISO classified area.

. 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.

. Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site specific procedures relative to their job functions.

. Complete cGMP documents as required and assist site and corporate Quality Assurance including, but not limited to:

o Investigations

o Corrective and Preventative Actions

o Deviations

o Out of Specifications

o No or Atypical Yields

o Manufacturing and QC Records

o Logbooks

. Attend internal meetings as required.

. Other assigned duties as required.

Skills:

Chemistry, Production, Gmp, Laboratory, Cleanroom, Quality control, Hplc

Top Skills Details:

Chemistry

Additional Skills & Qualifications:

. High school diploma required; associates degree in chemistry, engineering, or natural sciences preferred.

. Technical experience with computer-controlled automation preferred.

. Efficient in the use of MS Office Suite required.

. Ability to work various shifts and weekends required.

. Ability to be detail-oriented, accountable, patient, organized, and work in a team environment required.

. Ability to communicate professionally with colleagues and customers, have excellent attention to detail, and be dependable and responsible in a fast-paced, highly technical environment required.

. Ability to lift 50 lbs. required.

. Up to 5% travel required.

Experience Level:

Entry Level

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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.