Production Manager
Company: SOFIE
Location: Decatur
Posted on: November 15, 2024
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Job Description:
Production Manager
Making sure you fit the guidelines as an applicant for this role is
essential, please read the below carefully.
The Production Manager will supervise and coordinate all
production-related activities at a site level.
Essential Duties and Responsibilities
Normal Production/QC technologist duties, in addition to the
following:
Act as the facility liaison for the RCM group and contract par
Complete required synthesis units' operation training.
Monitor routine synthesis unit parameters.
Assist in routine, non-routine, and emergency maintenance on the
synthesis unit.
Have extensive knowledge of the operational principles of the FDG
and other drug products synthesis units used at the respective
site.
Ensure completion of documentation related to synthesis unit
operations for all production employees.
Oversee and assist in the preparation and set-up of the synthesis
unit as well as the safe delivery of the final product to the
pharmacy.
Perform routine synthesis unit preventative maintenance.
Oversee inventory of supplies used in FDG, and all other products
manufacturing.
Provide information to Facility Manager regarding equipment
operation and status.
Perform basic operations of the particle accelerator.
Assist the cyclotron engineer, as required, in the maintenance of
the accelerator.
Performs QC on manufactured batches and provide basic QC
support.
Perform radiation safety duties to assure compliance with all
regulations as required.
Assure compliance with all procedures, regulations, organizations,
etc.
Data gathering of manufacturing metrics.
Provide cyclotron operation coverage when required by
necessity.
Assimilate the basics of cGMP.
Demonstrates a commitment to quality.
Ensures equipment is running optimally and that production
employees are performing up to SOFIE standards.
Responsible for accurately managing inventory (spare parts and
consumable materials as required by TSG).
Responsible for accurately managing Physical Inventory.
Responsible for completing a weekly "Critical Inventory"
spreadsheet.
Responsible for ensuring the "Daily Summary" in the Production
Database (which reports to the Operation's database) is filled out
by production employees at the end of each day.
Responsible for attending a weekly Production Manager conference
call during work hours and outside of work hours..
Responsible for seeing that a Deviation Report is properly
investigated and documented.
Responsible for production employees' scheduling as well as
approving PTO's and tracking vacations.
Responsible for ensuring the production and QC departments are
clean and organized. This includes ensuring the workspace is
sanitized and floors are mopped by technicians.
Responsible for tracking radiation exposure of production personnel
and seeing that principles of ALARA are maintained.
Responsible for ensuring all company procedures as well as
Production and QC SOPs are implemented and followed.
As a Production Manager, you will be issued a company cell phone
and must be available 24/7 for technical or administrative
support.
Responsible for training new personnel.
Responsible for annual performance review of all production
personnel .
Responsible for finding ways to reduce production costs and
responsible for working with the pharmacy manager to stay within
budget.
Responsible for keeping the synthesis units maintained. Sunday is
normally preventative maintenance day.
Responsible for monitoring your site's production performance. May
be asked to collect data, prepare spreadsheets, or prepare graphs
for analysis.
Responsible for communicating with other department managers to
discuss operations, issues/concerns, new ideas, and continuous
quality improvement.
Responsible for logging all incoming inventory and making sure they
pass Acceptance criteria per SOPs as required per site.
Responsible for communicating with the pharmacist on duty to inform
him/her of late productions, problems with the cyclotron, issues
with chemistry, or any problem that could cause doses to be late to
our customers.
On weekly calls.
Clear and concise communication within department.
All other duties as assigned.
Education and/or Experience
Certified Cyclotron engineer or operator.
SOFIE Production tech training.
SOFIE QC training.
SOFIE Radiation safety training.
Hands on knowledge in production and QC.
High School Diploma or GED.
Must be able to read, write, and speak English.
Associates Degree or equivalent in a Technical Discipline; either
electronics or mechanical competencies (Preferred).
Ability to perform diagnosis and repair on common electronic
equipment (Preferred).
Working knowledge of electronic test equipment (Preferred).
Mechanical tools used in chemical processor maintenance.
Ability to read and comprehend simple instructions, short
correspondence and memos.
Ability to write simple correspondence.
Ability to effectively present information in one-on-one and small
group situations to customers, clients and other employees of the
Company.
Ability to add, subtract, multiply and divide in all units of
measure, using whole numbers, common fractions and decimals.
Ability to compute rate, ratio and percent and to draw and
interpret bar graphs.
Ability to define problems, collect data, establish facts and draw
valid conclusions.
Ability to interpret an extensive variety of technical instructions
in mathematical or diagram form and deal with several abstract and
concrete variables.
Working knowledge of MS Office applications.
In depth knowledge of production logging software, Millennium, and
other applications.
Basic understanding of DOS commands is preferred.
Individual must be detailed oriented, accountable, patient, and
must be able to work in a team environment with minimum
supervision.
Climb ladder and stairs.
Operate in confined spaces i.e. inside or underneath the
cyclotron.
Able to lift a minimum of 50 pounds.
Perform tasks requiring fine motor skills i.e. work repeatedly with
small parts.
Occupational exposure to ionizing radiation.
Shift work including but not limited to weekend call shifts.
General chemistry lab work i.e. handling of acids and bases
including but not limited to sulphuric acid and sodium
hydroxide
Clean driving record
Ability to travel to accounts and trade shows as necessary.
Strong interpersonal skills for interacting with all levels of the
company.
Experience in problem solving.
Strong management skills necessary.
Keywords: SOFIE, Springfield , Production Manager, Professions , Decatur, Illinois
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