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Take a look at a new profession. If you enjoy working with your hands, if the bioscience world intrigues you, the Bioscience Boost Training program will introduce you to this exciting industry. Those who successfully complete this program will have the opportunity to talk with recruiters for industry employers who are currently hiring for position openings.
* This session of the Bioscience Boost program is being funded by a Workforce Innovation in Regional Economic Development (WIRED) grant from the US Department of Labor, Employment and Training Administration working in the partnership with the Colorado Department of Labor and Employment, the Metro Denver Economic Corporation, and the City and County of Denver’s Office of Economic Development.
The typical pharmaceutical and medical device jobs titles would be - see sample job descriptions:
Manufacturing Technician Quality Control Technician Analytical Chemist for the Quality Control Department Microbiologist for Environmental Monitoring Department Environmental Monitoring Technician Raw Material Purchasing Quality Assurance Associate Inventory Control and Manager
This training program is available in two locations:
Fort Collins
Schedule
October 3 - November 4, 2009
Mondays & Wednesdays
6:00pm - 9:00pm
and
Saturdays
8:30am - 3:30pm
Registration
Step 1
Contact FRCC by phone at (970) 204-8686 or email to continuing.education@frontrange.edu to obtain a voucher to take a pre-course assessment test at the FRCC testing center.
Step 2
Fort Collins FRCC Testing Center is located in the Mount Antero Building.
4616 South Shields St., Fort Collins, CO www.frontrange.edu/testing
Bring your voucher to the center and allow 90 minutes or the test in basic arithmetic and reading. To view study guides, go to www.frontrange.edu/testing.
Step 3
Bring a hard copy of your test results and your Driver’s License or Passport to the Continuing Education department in the Mount Antero building on the Larimer Campus. All testing must be completed and reported for registration by September 28. Successful
test scores will qualify registration in the Bioscience program for the first 20 students to enroll.
Westminster Campus
Schedule
Tuesdays & Thursdays
September 1 - October 1, 2009
6:00pm - 9:00pm
and
Saturdays
September 12 - October 3, 2009
8:30am - 3:30pm
Registration
Registration is closed for the current session, please see information for training in Fort Collins.
Step 1
Contact the FRCC Continuing Education office by any one of the following:
You will be issued a voucher to take the entrance test to be assessed in basic math & reading comprehension. You are not formally registered in the class until you bring the test results back in person to our office and the receptionist will confirm whether you met the minimum scoring requirement to register.
Go in person:
FRCC Continuing Education - Westminster Campus
3645 W. 112th Ave
Westminster, CO
Room C2014 (on the far north east end of the campus building)
Find us on a map Call us: 303.404.5465
Step 2
Take the entrance test
The registration assistant in Continuing Education will give you a hardcopy email of the voucher to take the test . You will need to bring that with you along with a valid ID to the testing center on any FRCC Campus.
The deadline to take the test is Thursday, August 27, 2009. Space in the class is limited so take your test early.
Step 3
Bring your test results to the Continuing Education office in person
If you meet the minimum requirement, the registration assistant will register you in the class. You will be given forms to fill out at the Continuing Education office for this process.
Training Modules
Bioscience Industry Overview
This first module will provide an overview of the transformation cycle of a bioscience product from concept to commercial market. Discussion will compare and contrast the three cultures of Research & Development (R&D), production and Quality Assurance (QA/QC).
Introduction to cGMP
This module will review cGMP guidelines for ensuring
product is manufactured to requirements including
identity, strength, quality, and purity. Regulations
related to biological products and electronic records
and signatures and others will be discussed including
consequences of not following regulations. A brief
overview of Good Lab Practices (GLP), and Good Clinical
Practices (GCP) will also be covered.
Global Regulatory Standards
This module will include an overview of the code of
federal regulations FDA industries need to abide by
with a brief discussion on global regulations and what
the future holds for efforts to unify these standards.
QA/QC Roles and Responsibilities
This module will address handline bio-safety, potency,
and impurity profile issues for biological products including
setting appropriate product specifications
and expiration dates and general meeting the FDA
requirements for Quality Systems.
Good Documentation Practices
Documentation consistency is a key element to ensure
quality as well as regulatory expectations. This module
will review the cGMP expectations for documenting
work performed.
Deviations/Investigations/CAPA
Deviations/Investigations/CAPA: Any deviation from approved
cGMP processes needs to be documented, investigated,
and approved. A corrective action/preventive
action program ensures that adequate actions are taken
to eliminate and correct problems.
Change Control/Complaints/Recalls
This module will cover three cGMP quality systems –
equipment/process/facility change control, customer
complaints, and product recalls.
Quality Auditing Fundamentals
Quality Auditing Fundamentals: This module will cover
basic industry standards for auditing of cGMP facilities,
equipment, processes, and personnel.
History of FDA/Inspection Preparation
Preparing yourself and your facility for inspection by the
Food and Drug Administration will be covered in this
module along with some of the history that resulted in
today’s regulatory environment.
Communication & Integrity in the Workplace
Good interpersonal communication skills are key to getting
along well with co-workers, effectively working through
conflict, and avoiding frustration and waste caused by
poor communication.
This interactive module will guide participants through
hands-on activities practicing good communication
skills and the correlation with personal integrity in the
workplace.
Project Management
This module will provide a brief overview of project
management fundamentals including principles and tools
relevant to application in an FDA regulated industry.
OSHA Safety
Participants will be introduced to basic safety requirements
in manufacturing areas including hazard and risk
assessment, PPE, process and regulations of packaging
& distribution of bioscience materials, and actions directed
to risk reduction in production facilities, etc.
Manufacturing Job Knowledge
This module will overview common job duties/expectations
in a manufacturing process including operating
in the Windows environment for data entry tasks, an
introduction to clean room classifications, and reading
charts and graphs used to track and document product
throughout the process.
Testing
Participants will be tested at the end of each unit to
demonstrate transfer of knowledge and skills. Upon
successful completion of the program participants
will receive a certificate of completion listing course
competencies.
Sample Job Descriptions
Packaging Technician
Essential Duties & Responsibilities
- Perform a variety of packaging and manufacturing operations using manual and/or automated processes and equipment according to production batch records and procedures.
- Perform set-up, change-over and operation of labeling and packaging equipment.
- Utilize production equipment to label and package pharmaceutical product. Typical basic production equipment utilized includes, but is not limited to:
- Pouch Sealing equipment
- Syringe, vial, and jar Labelers
- Semi-Automatic Lot printing equipment
- Automatic cartoning equipment
- Testing/Measuring Equipment (scales, balances, checkweighers, burst testers, etc.)
- Environmental Monitoring Equipment (particle counters, air samplers)
- Accurately record in and maintain log books, production records, and associate documents to comply with regulatory requirements,
- Clean manufacturing areas as required by Standard Operating Procedures.
- Perform other duties as assigned.
Knowledge, Skills & Abilities
- Working knowledge of current Good Manufacturing Procedures (cGMP) as they relate to production packaging activities.
- Basic arithmetic and writing skills to document production activities in batch records.
- Strong communication skills to interact with Supervisors and colleagues.
- Ability to operate on a fast-paced manual assembly line and with basic production equipment.
- Ability to remain focused and detail-oriented during repetitive tasks.
- Ability to follow written production records and validation protocols.
- Ability to work independently and cooperatively on a team.
- Ability to stand for extended periods of time (up to 8 hours or more).
Process Operator
Essential Duties & Responsibilities
- Initiate, setup and operate production equipment to fill, label, and package pharmaceutical products. Production equipment utilized includes, but is not limited to:
- Syringe jar, tube and vial fillers
- Labelers
- Balances/Scales
- Pumps
- Mixers/Dissolvers/Homogenizers/Emulsifiers
- Thermoform/blister packaging equipment
- Cartoners
- Miscellaneous Packaging equipment (sealers, jet coders, hot stamping, etc.)
- Plan, initiate, setup and formulate bulk quantities of pharmaceutical products in a controlled environment according to production batch records within GMP requirements.
- Review and maintain log books, production records, and associate documents to comply with regulatory requirements
- Clean and sample processing equipment and manufacturing areas according to Standard Operating Procedures.
- Troubleshoot production equipment and work with Facilities to resolve machine issues.
Knowledge, Skills & Abilities
- Working knowledge of current Good Manufacturing Practices (cGMPs).
- Ability to initiate, setup and operate production equipment in all phases of manufacturing of pharmaceutical products and medical devices.
- Ability to setup and initiate formulation of pharmaceutical products using bulk formulation equipment according to production batch records.
- Ability to follow oral instructions, written production procedures, validation protocols, and work instructions/SOPs and sequence tasks as required.
- Ability to stand for extended periods of time (up to 8 hours or more).
- Ability to meet gowning requirements. May include hairnet, shoe covers, lab jacket, face mask, nitrile or latex gloves, beard cover (if appropriate), safety glasses, steel toed shoes, tyvek coveralls. Use of respirator may be required.
- Effective communication skills with the ability to work independently and cooperatively on a team.
- Basic arithmetic and writing skills to record data and equipment settings.
If you do not find what you are looking for, please contact our customer service staff at (303) 404-5465. Please contact Bao Xiong, (303) 404-5345 or bao.xiong@frontrange.edu, if you have any questions regarding this page.
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