Core Hours: Monday - Friday 2:00pm - 10:30pmKey Responsibilities
Perform job responsibilities in accordance with standard operating procedures
(SOPs) and production records with an expectation of "Right the First Time".
Record data in notebooks or lab forms and accurately calculate results to
support process.
Perform job in a clean room environment requiring clean room gowning,
including but not limited to:
Company-provided Scrubs
Shoe Covers and Sterile Boot Covers
Hairnets (and beard covers as applicable)
Tyvek Coveralls
Gloves
Full-face masks/hoods
Goggles
Chemical Protection PPE
Set up and operate labeling equipment used to label pre-filled syringes
and/or vials, including equipment in the sterile support areas.
Properly load pre-filled syringes and/or vials into labeling equipment.
Set-up and operate of semi-automatic packaging equipment used to package
pre-filled syringes.
Property load pre-filled syringes and components into semi-automatic packaging
equipment.
Formulate bulk materials.
Weigh, measure, and check raw materials to assure batches contain proper
ingredients and quantities.
Perform facility cleaning of manufacturing areas as required to maintain a
cGMP environment and by TOLMAR Standard Operating Procedures.
Set up and operate bulking operations.
Identify need for minor maintenance on aseptic production equipment and assist
with set-up.
Properly perform the Done By function on batch records in accordance with cGMP
standards.
Assist with equipment steam in place (SIP) on equipment used for sterile
bulking processes.
Ensure that product quality adheres to approved specifications.
Assist and support any aseptic process development activities/projects as
determined by Aseptic Development Operations Manager.
Handle hazardous raw materials and cleaning solutions following all applicable
safety procedures and policies.
Perform other duties as assigned.Special Skills and Knowledge
Working knowledge of current Good Manufacturing Procedures (cGMP).
Ability to stand for extended periods of time (up to 8 hours or more).
Understanding of basic computer software.
Ability to maintain focus on detail-oriented, repetitive tasks.
Good verbal and written communication skills.
Ability to follow and understand written production records and validation
protocols.
Understanding of basic math and writing skills to document production
activities in batch records and/or log books.
Must be able to keep accurate records and able to perform mathematical
calculations.
Ability to legibly complete required documentation.
Strong attention to detail required for documentation in production documents.
Capability to operate on a fast-paced manual assembly line using basic
production equipment.
Ability to learn Aseptic technique and work in an aseptic environment.
Ability to wear respirator for extended periods of time while working on tasks
(up to 4 hours).
Ability to lift up to 40 lbs.
Ability to lift arms above shoulder height repetitively for duration of shift
while cleaning.Core Values
The Manufacturing Operator I - Pali is expected to operate within the
framework of Tolmar's Core Values:
Consistently operate with the highest standards of ethics and compliance.
Take ownership of your actions, success and setbacks.
Respect each other and understand that honest collaboration is at the heart of
our company success.
Go the extra mile to make things happen.
Be committed to all we do and the patients we serve.
Embrace change with enthusiasm.
Strive to learn about and understand the needs of customers and patients,
and take action with great speed and efficiency no matter the task.
Communication
Interact with peers and members of other departments in team settings in a
professional manner.Education & Experience
High school diploma or equivalent required.
One or more years of experience in an aseptic (sterile) manufacturing
environment preferred.
Two or m re years of experience in a manufacturing role required.Additional Requirements
Shift work in a manufacturing and warehouse environment.
May require overtime.
Passing results on an internal inspection qualification for syringe inspection
on semi-automated equipment for one syringe type.Working Conditions
Working conditions are normal for a Manufacturing EnvironmentCompensation and Benefits
Pay: $23.33 per hour
Shift Differential: $1.50 per hour