Job Description

Job Description

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.
• CAPA and deviation investigation and analysis
• Audits
• Oversees the entire quality process of the lab and implement the procedures
• Assist with documentation, verifying and keeping records on incoming and outgoing shipments.
• QC Sampling
• 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. As needed .
• Cryopreservation and thawing. As needed .
• 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. As needed.
• 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 QC and laboratory experience in an industrial biomedical/biotechnology laboratory setting.
• Experience in cell biology techniques, aseptic technique, Serological pipetting 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.

Job Types: Full-time, Permanent

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee discount
• Health insurance
• Paid time off
• Professional development assistance
• Vision insurance

Education:

• Bachelor's (Required)

Experience:

• Quality systems: 2 years (Preferred)
• Aseptic technique: 1 year (Required)
• Pipetting: 2 years (Required)

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