What are the responsibilities and job description for the Manufacturing GMP Support position at eTeam, Inc.?
Job Title : Manufacturing GMP Support
Location : South San Francisco, CA 94080
Duration : 12 Months
Shift : Night shift hours are 7pm-8am 3 days one week 4 days the next week. N1 team is Sun-Tues N2 is Wed-Fri both teams alternating Saturdays
Pay Range : $20.00 to $23.57
Job Description :
Responsible for producing innovative bio-therapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment and maintain areas in high state of inspection preparedness.
Perform cleaning and disinfection of ceilings, walls, floors, equipment, and surfaces in a cleanroom environment.
Comply with annual Aseptic medical evaluations
Operate and support manufacturing equipment such as the autoclaves to prepare for GMP processing.
Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP).
Responsible for being proficient in one functional area.
Understands and applies biological, chemical, and mechanical principles and techniques.
Job Responsibilities :
Perform sanitization and cleaning per governing SOPs in Grade A / B GMP spaces.
Clean, assemble, and sterilize equipment using washers and autoclaves.
Perform facility FIT walkthroughs and create work orders to fix any issues observed.
Monitor and perform audits of tasks such as cleaning and pest control operations within classified environment.
Responsible to participate in cycle counting and inventory of sanitization supplies and gowning articles in order to maintain inventory levels for timely reordering.
Operate systems that clean and sterilize tanks and filtration systems.
Prepare solutions for the production process.
Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
Troubleshoot equipment and process problems.
Comply with safety requirements, cGMP, SOP and manufacturing documentation.
Use of automation to perform production operations.
Provide support to Manufacturing to meet production demands.
Operate automated systems for equipment operation.
Assemble and prepare equipment for production.
Exhibit detail-oriented documentation skills Communicate effectively and ability to work in a team environment.
Exhibit professional interpersonal skills.
Work with coworkers and supervisor to effectively troubleshoot minor equipment and process issues.
Follows established safety and environmental guidelines and procedures for all work performed.
Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.
Fosters a positive safety culture in which no one gets hurt.
A good working knowledge of biopharmaceutical technology and processes.
Trained and skilled in all operational procedures of at least one manufacturing department.
Demonstrated ability to independently document and record information related to the process.
Occasionally makes routine decisions based on experience.
Identifies and suggests solutions to common basic problems.
Recognizes non-routine problems, investigates and suggests potential solutions.
Judgment is required in resolving problems and making routine recommendations.
Ability to recognize deviation from accepted practices is required.
Job Requirements Education and Experience :
High School and 1-3 year related experience working in a GMP work environment.
Biotech certificate from approved program.
Strong oral and written communication skills.
Familiarity of computer-based systems.
Background in fermentation
Ability to receive, interpret, and provide basic information and materials involved with the day-to-day activities of performing the job.
Work Environment / Physical Demands / Safety Considerations :
Schedule could include a non-rotating 3 or 4-day (12 hour shift including one weekend day), evening or night hours, or full off-shift hours.
Expected to be on feet for 8 to 10 hours a day.
Climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility.
Lift up to 25 lbs., Carry 25 lbs., Push / Pull force of 50lbs with full body, and Push / Pull force of 24lbs with arms only may be required.
Ability to bend and lift items from floor level, work with arm extended at chest height while making fine hand and finger manipulations, extend arms above shoulder level to manipulate equipment, and repetitive fine motor skills.
The clean room environment requires : Gowning in the form of hospital scrubs, coveralls, gloves, and steel toe boots must be worn No makeup or jewelry can be worn when working in the clean room environment Work in a clean room environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water, and air together this creates a loud environment.
Work with hazardous materials and chemicals.
Salary : $20 - $24
