Description:
Note:
ONSITE - USRI - PLEASE NOTE SHIFT REQUIRMENT BELOW

Please make sure candidates are aware this is a night shift role and include confirmation of this as a summary at top of candidate's resumes.

• 1 EW needed for Rotating night shift (C shift)
• 7 PM – 7 AM ET (12 hour day)
• Five (5) working days in one week and two (2) working days the following week
• 1 EW needed for Rotating night shift (D shift)
• 7 PM – 7 AM ET (12 hour day)
• Five (5) working days in one week and two (2) working days the following week
• What type of qualities/characteristics are you looking for in candidates to work best with your team? 
• Previous bio pharma experience, clean room behavior experience, the team needs someone who can work in a fast paced/agile environment. 
• EW will need to be comfortable managing change.
• What is your minimum education and work experience requirements you think it suitable for this role? 
• B.S. 2+ years. GMP knowledge, previous pharma experience, QA experience, good communication, and decision making.

Job Details:
In this vital role, will be responsible for PQA (Plant Quality Assurance) On the Floor in support of Manufacturing activities. This position requires working directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations.

Responsibilities Include the Following:

• Provide Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current applicable regulations.
• Ensure that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations.
• Performs review and approval of cGMP processes, procedures, documents and records. Review logbooks, batch records, attachments, work orders, and other GMP documentation.
• Ensure that deviations from established procedures are documented per procedures.
• Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• Alert management of quality, compliance, supply and safety risks.
• Complete required assigned training to permit execution of required tasks.
• Responsible for being in clean room space for majority of time on shift which includes gowning in and out of frocks and coveralls.
• Communicating and collaborating with the PQA shift to ensure required tasks are completed

Basic Qualifications:     

• High school/GED + 4 years work experience or Associate + 2 years work experience or Bachelor + 6 months work experience or Masters Degree.

Top 3 Must Have Skill Sets:

• Quality Experience, Cleanroom Experience, Ability to Follow SOPs

Pay Rate- between $30- $35/Hr. on W2 based on experience.

"This posting is for Contingent Worker, not an FTE"