QC/Production Associate I - #1398361
SOFIE
Date: 3 weeks ago
City: Haverhill, MA
Contract type: Full time
Title | QC/Production Associate I
Department | Network Operations
Reports To| Facility Manager
Overview
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
Department | Network Operations
Reports To| Facility Manager
Overview
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):
- 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 of the synthesis unit
- 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:
- Maintain production/QC/cleaning supply levels as appropriate
- Assist with inventory reporting
- 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.
- Complete cGMP documents as required and assist site and corporate Quality Assurance including, but not limited to:
- Investigations
- Corrective and Preventative Actions
- Deviations
- Out of Specifications
- No or Atypical Yields
- Manufacturing and QC Records
- Logbooks
- Attend internal meetings as required.
- Other assigned duties as required.
- 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.
How to apply
To apply for this job you need to authorize on our website. If you don't have an account yet, please register.
Post a resumeSimilar jobs
In-Plant Solutions Specialist-Magellan
MSC Industrial Supply Co.,
Haverhill, MA
1 week ago
BUILD A BETTER CAREER WITH MSC Serving customers and our community starts with the best people doing their best work. That is precisely what we have created at MSC Industrial Supply Co. We are a leading North American distributor of metalworking and maintenance, repair, and operations (MRO), products and services. We offer more than 2 million products and have over...
Behavioral Health Associate - Part Time (24 Hours) - 11pm - 7:30am
Haverhill Pavilion Behavioral Health,
Haverhill, MA
1 week ago
When you join the Haverhill Pavilion team, you're not just taking a job, you’re making a positive impact in patients' lives. The Role As a Behavioral Health Associate, you are an integral part of the treatment team provided for patients upon admission to our facility. Each unit utilizes a team nursing approach to take care of our patients. Nurses work...
Pharmacy Manager
SOFIE,
Haverhill, MA
3 weeks ago
Job Description | Pharmacy Manager Title | Pharmacy Manager- Department | Operations Reports To | Director, Operations Overview The Facility Manager’s primary role is to ensure all radiopharmacy operations within their site are performing to the standards set by SOFIE. The Facility Manager should be the key driver of quality and safety for the site. Essential Duties And Responsibilities ...