Manufacturing Associate I
Company: Fladger Assoc. Inc.
Location: Hinkley
Posted on: May 15, 2022
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Job Description:
Job Description Fremont, CA Contract Duration: 6-24 months Rate:
Negotiable Responsibilities: Excellent employment opportunity for a
Manufacturing Associate I in the Fremont, CA area. Prepare a
variety of media and stock solutions that are transferred from tank
to bag or tank to tank in order to support cell culture main
operations to facilitate proper cellular growth per SOP. Able to
follow SOPs to perform routine cleaning activities of parts and
equipment using manual cleaning methods, designated parts washers,
Clean-In-Place (CIP) and COP(Clean-Out-Of-Place) systems. As well
as collecting rinse water samples and performing swabs on required
equipment for testing. Execute proper documentation and measures to
initiate changing over of parts and equipment to be released for
use. Performs a majority of operations in a cGMP clean room
environment. Practices ergonomic safety and use appropriate
personal protective equipment (PPE) in all operations. Documents
execution of operations through the Bio Manufacturing Execution
System (BioMES), batch record and equipment use logbook using Good
Documentation Practices (GDP). Interchanging between electronic and
paper documentation procedures. Performs internal support duties
including stocking consumables/materials, updating controlled SOP
binders, appropriately discarding expired reagents, recognizing and
reporting process and equipment anomalies. Reports any issues
related to manufacturing performance, process and safety to the
team lead or Manager in order to ensure safety and compliance with
regulations and cGMPs and to facilitate continuous process
improvement. Participates in training and development opportunities
in order to gain an understanding of SOPs. Performs routine
housekeeping of the manufacturing plant using the 5S organization
methodology by using appropriate equipment safety signage, labeling
of parts-in-process, sweeping water pools to the floor drain, and
picking up parts from the floor. Collaborates within team and
department in order to follow best practices and meet department
goals. Experience: Requires a High School Diploma or equivalent
plus four (4) years closely related Technical experience,
preferably in a Pharmaceutical or Chemicals Manufacturing
environment. An Associates Degree with a minimum of two (2) years
closely related Technical experience, preferably in a
Pharmaceutical or Chemicals Manufacturing environment; or a
Bachelors Degree, preferably in a Science or Engineering field is
preferred with 1 years of GMP exp. Experience working with
established GMP procedures and bulk manufacturing. Technical
knowledge of manufacturing systems, methods and procedures.
Understanding of cell culture processes. Demonstrated ability to be
organized and work well in small work groups. Must be able to
assist in trouble shooting activities and repairs to production
equipment under the guidance of more experienced technicians.
Demonstrated mathematical skills, including the ability to perform
addition, subtraction, multiplication, division, and conversions.
Demonstrated ability to read, comprehend, and follow written
instructions. Demonstrated written and verbal communication skills
are required. Experiences in related Biotechnology/Pharmaceutical
industry strongly preferred Must be able to learn and perform basic
computer operations such as MS Office and Outlook and other
computer-based software Preferred skills: Current Good
Manufacturing Practices, Mammalian cell culture, Bio Manufacturing
Execution System (BioMES), Process Control System DeltaV,
Laboratory Management Information System (LIMS) Physical Demands /
Surroundings Requires physical activity such as almost constant
standing, walking, eyestrain, etc. Must be able to occasionally
lift up to 25 lbs. Works regularly under desirable conditions with
some moderately disagreeable conditions in the manufacturing
setting. Entry level in subject matter Schedule: Sunday -
Wednesday, 6:00AM - 4:30PM Required Skills: CGMP Additional Skills:
MEDIA PREP, CLEAN ROOM, COMPUTER OPERATIONS, DELTAV, DETAIL
ORIENTED, DOCUMENTATION, ENTRY LEVEL, INDUSTRIAL/MANUFACTURING,
GMP, LABORATORY, LIMS, MAMMALIAN CELL CULTURE, MS OFFICE,
OPERATIONS, OUTLOOK, PROCESS CONTROL, PROCESS IMPROVEMENT,
INDUSTRIAL, FOOD INDUSTRY, PRODUCTION EQUIPMENT, SOP, SOPS,
TRAINING, BATCH RECORD, CELLULAR, EXCELLENT WRITTEN AND VERBAL
COMMUNICATION SKILLS, MAINTENANCE, MICROSOFT OFFICE, MICROSOFT
OUTLOOK
Keywords: Fladger Assoc. Inc., Victorville , Manufacturing Associate I, Other , Hinkley, California
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