REQUIRED QUALIFICATIONS:

• High School Diploma or equivalent with 2 years experience in working in the pharmaceutical industry and/or within aseptic clean room environments OR Bachelor degree in a technical field.
• Candidates may be required to work in an aseptic gowning environment to perform job duties. Aseptic gowning requires that all skin and hair are covered through wearing the following:  Beard/moustache cover, hair net, hood and face mask, goggles, jumpsuit, gloves and boots.
• Candidates are willing and able to lift 50 lbs.
• Multiple shifts are available.  Shift requirements will vary based on the position you are selected for.  Shift preferences will be requested if selected for interview.
• Experience with batch record execution, including good documentation practices.

PREFERRED QUALIFICATIONS:

• Demonstrated 1-2 years of leadership experience
• BioWork Certificate (working in an FDA regulated industry)
• Certified Yellow Belt
• Proficiency in the use of SAP in a manufacturing setting
• Execution of Paper or Electronic Batch Records

REQUIRED QUALIFICATIONS:

• Bachelor of Science Degree in Engineering or Life Sciences

Required Experience and Skills

• Effective technical problem-solving abilities
• Demonstrated effective written and verbal communication skills; ability to influence both peers and management in consensus
• Strategic and effective collaboration and leadership skills

Preferred Experience and Skills

• Bulk upstream and/or downstream vaccine processes within a cGMP environment
• Facility, equipment, and process start-up in a sterile GMP environment
• Validation in support of GMP process demonstration (IQ/OQ/PQ)

REQUIRED QUALIFICATIONS:

• Bachelor degree preferred; Candidates with an Associate degree will be considered pending relative experience; Minimum of an internship or one (1) year of relevant post-degree work experience in GMP-related field, including Technical, Engineering, Quality, or Operations
• Knowledge and exposure to fundamental theories, principles, and concepts in the Quality Assurance discipline , including the knowledge and understanding of pharmaceutical operations systems
• Technical writing capabilities and be able to compile straightforward investigations and procedures
• One to four years pharmaceutical industry exposure
• Comprehends and applies regulatory/compliance requirements, including GMP, NDA, and related regulations, and has the ability to interpret those regulations for implementation in the workplace