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Job description
Job DescriptionJob DescriptionWe are seeking energetic and detail-oriented Laboratory and Manufacturing Associate I & II to join our dynamic team. In this role, you will play a vital part in supporting manufacturing operations and laboratory activities, ensuring high-quality production and compliance with industry standards. This position offers an exciting opportunity to develop your skills in a fast-paced environment, contributing to innovative solutions and efficient processes. Whether you are just starting your career or bringing previous experience, you will be empowered to make a meaningful impact every day.
Assist managers in registering bioprocesses info. into database.
Follow Chief Scientific officer and quality assurance executives'/management guidelines and expectations and tasks assigned.
Assist with documentation, verifying and keeping records on incoming and outgoing shipments.
Prepare all Microbiology and Endotoxin Samples for shipping to outside vendor (lab), including but not limited to final visual inspection, documentation, labeling or stamping and packaging.
Cryopreservation and thawing.
Read, write, and follow standard operating procedure, technical Lab forms and validations.
Maintain accurate laboratory and Batch records within the system (hard copies and soft copies).
Perform Cell Isolation Processes for all available technologies in controlled environmental room, tissue processing, Process disposables supplies and reagent inventory.
Perform product testing per ISO/IEC 17025 methodology. Follow and maintain the product testing requirements and guidelines.
Follow and maintain defined responsibilities of Aseptic operations.
Follow and maintain company’s strict confidentiality requirements.
Process and discard any failed bioprocess batches per SOP.
Maintain correct records for all bioprocesses and biobanking.
Maintaining the physical Cryo-storages and products locations per SOP.
Work with vendors to evaluate new equipment and reagents.
Assist shipping/handling dept. for products packaging & delivery as needed.
Examine outgoing shipments to ensure shipments meet specifications.
Manage inventory of product as needed.
Environmental and quality control sampling
Review and sign off manufacturing final batch release.
Perform document overview to pre-determine approval/rejection.
Lead Quality Control.
Data entry
Compliance with duties assigned to be followed in respect to ISO 9001, ISO/IEC 17025, ISO 20387, GLP, GDP, GTP and GMP defined responsibilities.
Review processes and direct manufacturing overview.
Registering products info. into database and batch records.
Perform documentations, verifying and keeping records on incoming and outgoing shipments.
Maintain current knowledge of relevant scientific literature.
Manage inventory of products, as needed.
General Aseptic Manufacturing and quality control duties
Requirements:
Bachelor’s degree in the biological sciences or any other related scientific field and a minimum of 2 years full-time laboratory experience in an industrial biomedical laboratory setting.
Be able to work on weekends, if needed
Experience in cell biology techniques, cell culture and cell isolation are required. The ideal candidate will also have additional experience in microscopy, histology, manufacturing, and tissue surgical techniques.
Proficient in Aseptic and Sterility Techniques, assist in cell isolation, cell assays.
Knowledge and experience of GLP and/or GMP.
Knowledge and experience with Pipetting.
Knowledge and experience of developing and following SOPs.
Able to think creatively and solve problems.
Prior experience working in Strict Controlled environment- ISO 7 or ISO 5 (Class 100) cleanroom.
Very Detail-oriented
Strong written and oral communication skills
Ability to read and interpret documents such as blueprints, safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively.
Dependability - Follows instructions; Takes responsibility for own actions; Commits to long hours of work when necessary to reach goals.
Salary: $24-$26 per hour
Must be able to work on weekends if needed. (Overtime).
Average weekly working hours: 40-60 hours per week.
Benefits:
401(k)
Dental insurance
Employee discount
Health insurance
Paid time off
Vision insurance
Bonuses - 4 times in a year (up to $ 2000 annually - performance based)
Education:
Bachelor's (Required)
Experience:
General lab: 2 years (Required)
Bioprocess Manufacturing: 2 years (Preferred)
pipetting: 2 years (Required)
working under biological safety cabinet: 1 year (Required)
Aseptic technique: 1 year (Required)
Data entry: 1 year (Required)
Language:
English (Required)
Ability to Commute:
Aliso Viejo, CA 92656/ San Juan Capistrano (Required)
Work Location: In person
Pay: $24.00 - $26.00 per hour
Expected hours: 40.0 – 60.0 hours per week. Non-exempt.
Benefits:
401(k)
401(k) matching
Dental insurance
Employee discount
Health insurance
Paid time off
Vision insurance
Wellness program
Application Question(s):
What are your availabilities for an interview
Are you ok working on weekends when required ?
Are you okay with working overtime when required
The salary range is set and non‐negotiable. Would you like to proceed?
Education:
Bachelor's (Preferred)
Experience:
Industrial laboratory: 2 years (Required)
working under Biological safety Cabinet : 1 year (Required)
Aseptic technique: 2 years (Required)
Pipetting : 2 years (Preferred)
Data entry : 1 year (Required)
working in Clean room : 1 year (Preferred)
Language:
English (Required)
Shift availability:
Day Shift (Required)
Ability to Commute:
Aliso Viejo, CA 92656 / San Juan Capistrano (Required)
Work Location: In person
Company Description
Company Description
Worksite address
aliso viejo, CA, 92656, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.