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Manufacturing and Quality Control Lead

4 months ago

Aliso Viejo, California, United States Leo Corps, Inc. Full time
Job Description

Job Description

General Responsibilities include:
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.

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.
Experience in Auditing and Quality Control
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.

Company Description

Company Description

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