Job Description

Scope of Position:

• In this role, you will be directly reporting to the Quality Site Lead and indirectly to the Laboratory Technician to ensure Quality Control laboratory testing, incoming Quality Control raw material inspection, and document control support duties are completed to support the quality goals / metrics of the manufacturing plant. In doing so, you will directly support the growth of a Fortune 500 subsidiary responsible for manufacturing serum and media products for life science and pharmaceutical applications. We also look for you to comply to in-house and/or external specifications, standards such as cGMPs, 21 CFR 820, ISO 13485:2016, and Quality System Procedures.

Day to Day Responsibilities:

• Responsible for in-process and finished product testing of applicable products, both in-house and through management of contract testing laboratories (endotoxin testing, Hemoglobin, water quality testing, and other laboratory test protocols).
• Assists with tracking and trending data related to products or systems such as facility water or cleanroom air quality.
• Conducts incoming QC inspection and release of raw materials upon receipt.
• Understands the concepts of aseptic technique and be trained to operate inside Class 1,000 and Class 100 cleanroom areas.
• Assists with maintaining the product sample retention program.
• Assists with management critical dates of quality department deliverables and drive for on-time closure (i.e., release turnaround time, OOS investigations, nonconformances, CAPAs, etc.).
• Oversee controlled records management, including document control logging, scanning, and filing (i.e. calibration records, water testing, raw material CoAs, etc.) in a timely and efficient manner that allows for easy access for regulatory and customer audits.
• Conduct the review and revision of procedures, specifications and forms as needed.

Required Education:

- 4-year Biology Degree or Chemistry degree (bachelor's degree minimum required)

Required Years and Area of Experience:

- 1-3 years of experience in Manufacturing, Engineering and/or Quality; specifically in a laboratory setting.

Required Skills:

• Ability to develop, update and train on SOPs.
• Competent to learn to prior knowledge of ISO standards and Quality Management Systems (QMS).
• Good organizational skills; strong time management skills.
• Strong interpersonal and communication skills.
• Ability to follow detailed directions.

Desired Skills:

• Experience in a medical, pharmaceutical or biotechnology environment preferred
• Previous cell culture or microbiology laboratory experience preferred
• SAP and/or PeopleSoft experience preferred.
• Knowledge of computer programs, such as Word, Excel, Powerpoint, etc

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