QC Associate (I-IV)

Post

Position Summary

The Quality Control Associate will work within the Quality Department and be responsible for daily execution of tasks associated with quality testing cell culture products produced by Gemini in accordance with cGMPs. Our products are made aseptically and are sterile-filled following cGMPs. In addition, this person may be asked to assist, and/or perform tasks outside of direct product testing, such as cleaning the quality and laboratory spaces or to execute maintenance, calibration or validation protocols. This person will be expected to follow, and at times write and implement standard operating procedures (SOPs), work instructions (WIs) and device history records (DHRs) following FDA, USDA, and/or other applicable international guidance documents. This person will always be expected to collaborate as a team player with personnel in EHS, Engineering, Supply Chain, Manufacturing, Customer Service, Quality Assurance and Information Technology to effectively perform duties of manufacturing within Gemini.

Reporting Relationships

Direct Supervisor: Director, Quality or QA Manager (depends on layers)

Indirect Supervisors: Chief Operating Officer

Key Responsibilities

  • Testing raw materials (ex. Endotoxin, sterility, pH, Osmolality)
  • Testing finished product
  • Environmental monitoring
  • Sampling incoming material
  • Receiving critical raw material
  • Creating quality documents (ex. Certificates of Analysis, Certificates of Origin)
  • Assist with facility cleaning, operational maintenance or calibration
  • Assist with facility and process validations as required
  • Perform aseptic QC operations and validations
  • Pass and sustain aseptic qualifications which consist of passing gown qualification, maintaining gown access, passing Grade A qualifications, and performing Environmental monitoring during aseptic filling
  • Assist with clean room sanitization as required
  • Assist with or lead Deviation investigations/closures, CAPA closures or Change Controls
  • Document all work as required by cGMPs on a real time basis
  • Abide by all safety requirements as defined by the company
  • All other task assigned to you by direct supervisor

Skills/Abilities

  • Basic knowledge of the Scientific Method
  • Basic math skills, including simple algebra
  • Basic knowledge of and adherence to cGMP
  • Basic knowledge of chemistry and biology
  • Basic knowledge of steam/dry heat sterilization theories
  • Basic knowledge of OSHA Safety requirements
  • Good documentation skills
  • Ability to lift / move 40 lbs. overhead
  • Ability to learn how to operate all types of production equipment
  • Ability to read, understand and accurately follow company SOPs and guidelines

Personal Attributes

  • Willing to learn new tasks, skills
  • Responds quickly to assignments
  • Positive attitude
  • Displays understanding of and promotes company and customer objectives
  • Readily adapts to changing job duties
  • Works well in a team environment
  • Detail oriented

Required Skills and Experience

  • Degree or relevant experience in a technical, engineering or science-based discipline
  • Preferred > 1-year relevant experience in a biopharmaceutical manufacturing facility or equivalent experience in a current Good Manufacturing Practices (cGMP) or technical manufacturing environment
  • Knowledge of general, technical, manufacturing and QC operations
  • A proven ability to work as part of a team to deliver results
  • Organization Skills – Ability to manage multiple priorities and know when to escalate issues
  • Effective Communicator
  • Basic level of understanding with Microsoft Office Products (Word, Excel)

Company Values

  • Adaptable
  • Results driven
  • Decisive
  • Reliable
  • Innovative
  • Confident
  • Ethical

Job Type: Full-time

Experience:

  • Laboratory, validation, or GMP: 3 years (Preferred)
  • Aseptic Technique: 1 year (Preferred)
  • Quality Control: 2 years (Preferred)

Education:

  • Bachelor’s (Preferred)

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