MF Lead Operator - Pali
Company: Tolmar
Location: Windsor
Posted on: April 24, 2024
Job Description:
DescriptionCore Hours Vary, but Most Production Occurs Between
the Hours of 6am - 6pm
Key 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 semi-automatic labeling equipment used to
label pre-filled syringes.
- Properly load pre-filled syringes and/or vials into labeling
equipment.
- Set-up and operate semi-automatic packaging equipment used to
package pre-filled syringes.
- Set up and operate semi-automatic filling equipment used to
fill syringes for injectable products in both general manufacturing
and sterile manufacturing areas.
- Properly load pre-filled syringes and components into
semi-automatic packaging equipment.
- Formulate bulk materials.
- Perform facility cleaning of manufacturing areas as required to
maintain a cGMP environment and following TOLMAR Standard Operating
Procedures.
- Set up and operate compounding equipment used to produce bulk
material for injectable products.
- Perform final review of processes before the processes can be
considered complete.
- Properly perform job duties as a second checker, ensuring all
production activities are correctly performed 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.
- Correctly perform inspections of packaged components.
- Responsible for assembly, disassembly and sanitation of various
equipment.
- Train other Manufacturing Operators and Manufacturing
Technicians in the Aseptic Development team to perform job duties
related to their position.
- Review and maintain log books, production records, and
associated documents to comply with regulatory requirements, GMPs,
and TOLMAR Standard Operating Procedures.
- Perform visual and physical checks of in-process and finished
product as requested.
- Perform biological sampling of general manufacturing clean room
facilities.
- Perform 100% inspections of pre-filled syringes.
- Coordinate the daily tasks for Manufacturing Operators and
Technicians within assigned process.
- Coordinate materials, staffing and resources to support line
operations and changeovers.
- Ensure that employees in assigned process follow safe work
practices.
- Perform on floor, in process reviews of production batch
records for accuracy and resolve errors in real time.
- Operate under the guidance of a Manufacturing Manager.
- Perform other duties as assigned.
Special Skills and Knowledge
- Mastered knowledge of current Good Manufacturing Procedures
(cGMP) as they relate to production packaging activities.
- Ability to stand for extended periods of time (up to 8 hours or
more).
- Proficient in Microsoft Office (Excel, Word, and
Outlook).
- 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.
- Strong understanding of basic math and writing skills to
document production activities in batch records and/or log
books.
- Ability to keep accurate records and able to perform
mathematical calculations.
- Ability to legibly complete required documentation.
- Excellent attention to detail for documentation in production
documents and to inspect produced goods within specified
requirements.
- 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.
- Ability to provide support as well as direction to Process
Development personnel in the area.
- Ability to operate new production equipment with little to no
previous experience.
- Ability to lead others in proper aseptic technique and work in
an aseptic environment.
- Ability to quickly make decisions and understand the impact on
processes and employees.
- Technical ability to assemble and disassemble filing
equipment.
- Ability to provide consistent coaching, guidance, development
and mentorship to operators and technicians.
Core Values
- The Lead Operator - Aseptic Development 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.
- Ability to lead by example and have a proven record of
excellence in attendance, dependability and safety.
Education & Experience
- High school diploma or equivalent required.
- Engineering degree and/or equivalent previous experience in
engineering or process development preferred but not
required.
- Three or more years of experience in an aseptic (sterile)
manufacturing environment preferred.
Additional Requirements
- Acceptable results on both a quantitative and verbal assessment
test.
- Valid driver's license and acceptable motor vehicle record may
be required.
- Passing results on an internal inspection qualification for
syringe inspection on semi-automated equipment for one syringe
type.
- Shift work in a manufacturing and warehouse
environment.
- Overtime may be required.
Working Conditions
- Working conditions are normal for a Manufacturing
Environment
Compensation and Benefits
- Pay: $30.16 per hour
- Benefits summary:
Tolmar compensation programs are focused on equitable, fair pay
practices including market-based base pay and a strong benefits
package. The final compensation offered may vary from the posted
range based on the selected candidates qualifications and
experience.
Equal Opportunity Employer/Protected Veterans/Individuals with
DisabilitiesThe contractor will not discharge or in any other
manner discriminate against employees or applicants because they
have inquired about, discussed, or disclosed their own pay or the
pay of another employee or applicant. However, employees who have
access to the compensation information of other employees or
applicants as a part of their essential job functions cannot
disclose the pay of other employees or applicants to individuals
who do not otherwise have access to compensation information,
unless the disclosure is (a) in response to a formal complaint or
charge, (b) in furtherance of an investigation, proceeding,
hearing, or action, including an investigation conducted by the
employer, or (c) consistent with the contractor's legal duty to
furnish information. 41 CFR 60-1.35(c)
Keywords: Tolmar, Highlands Ranch , MF Lead Operator - Pali, Other , Windsor, Colorado
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