This position is primarily responsible for performing manufacturing activities in our specialty manufacturing lab.  The majority of day-to-day activity will be focused on manufacture, inspection, labeling, and packaging of products, including PSP (Patient Specific Primer) and WES (Whole Exome Sequencing) parts. The operations include handling cryogenic materials so attention to safety is critical.  This role will also provide essential feedback on new process development and assist in performing system validations.

RESPONSIBILITIES

• Manufacture product as specified in controlled manufacturing procedures, and in compliance with regulations and guidelines:
  • Cleaning and preparing laboratory on a daily basis
  • Organizing and maintaining consumables inventory utilizing Kanban system
  • Aliquoting of non-hazardous liquid reagents
  • Using basic lab equipment as trained
  • Clean, prepare, and assemble equipment for processing operations
  • Movement of consumables and finished product into appropriate locations
  • Adhere to Company policies and safety guidelines
  • Equipment PMs
• Documentation:
  • Assist in the preparation of reports and other documentation as applicable to the scope of manufacturing
  • Accurately complete documentation of manufacturing batch records using Good Documentation Practices
  • Accurately update applicable data into an ERP system
  • Assist with NCRs, RCAs, and RA as needed
• Additional responsibilities as assigned
• Review, understand, and comply with company’s HIPAA Security policies and procedures.

EXPERIENCE:

• 1+ years’ experience in an operations, manufacturing, or similar environment preferred.
• Good Manufacturing Practices (GMP) Experience at an FDA regulated biotech, pharmaceutical, or medical device manufacturer is a plus.
• Previous experience with manufacturing of class 2 and preferably class 3 Medical Device also is a plus.
• Experience with aseptic or molecular biology technique is a plus.

KEY ATTRIBUTES

• Demonstrates good verbal, listening and written communication skills. Strong attention to detail.
• Ability to foster and maintain relationships with individuals representing a wide diversity of disciplines and levels of sophistication in a collaborative environment.
• Deadline and deliverable driven individual with an ability to adapt to unexpected or abnormal results or situations.
• Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company.
• Self-starter driven to perform with the ability to organize and execute tasks.
• Technical accuracy and ability to perform mathematical calculations.
• Good computer skills
• Basic understanding of cGMP requirements per 21CFR820 preferred but not required.
• Basic understanding of ISO 13485 preferred but not required.

EDUCATION:   

• High School Diploma or A.S. degree in biological or physical science. Degree requirement may be waived with relevant experience in an FDA regulated, controlled production environment, including Manufacturing, Quality Control, Quality Assurance, and/or Materials Management.