This position supports daily manufacturing activities for non-sterile and sterile bulk/CSP operations.
Responsibilities may include:
- Perform line clearances, assure equipment is operating correctly, and assure Post Compounding checks are performed according to current SOPs and Batch Record Instructions
- Maintains records of every movement of Controlled and Non-Controlled Substances from the point they are received from compounding
- Ensures proper cleaning of the equipment in accordance with procedures
- Monitors the daily use of Controlled and Non-Controlled Substances throughout the process to assure people and processes are in a continuous state of compliance with DEA regulations, company policies and procedures and safety requirements
- Escalate issues to Operations and Quality Management
- Completes in-process checks & verifications of Controlled and Non-Controlled Substances in alignment with Standard Operating Procedures
- Reviews documentation, such as batch records, to ensure recording of processes, logs, and accounting of materials is in compliance with policies, procedures, and Good Documentation Practices (GDP)
- The incumbent will have and maintain a contemporaneous working knowledge in cGMP requirements
- Other duties that may reasonably be assigned from time to time by management / supervision
- Legally authorized to work in the job posting country
- High school Diploma or GED from recognized institution or organization required
- College Degree with an emphasis in Chemistry, Biochemistry or equivalent preferred
- Pharmaceutical experience preferred
- At least 1-year pharmaceutical manufacturing a plus
To be considered:
In order to be considered for this position you must complete the entire application process, which includes answering all prescreening questions and providing your eSignature on or before the requisition closing date.
Candidates for regular U.S. positions must be a U.S. citizen or national, or an alien admitted as permanent resident, refugee, asylee or temporary resident under 8 U.S.C. 1160(a) or 1255(a)(1). Individuals with temporary visas such as E, F-1, H-1, H-2, L, B, J, or TN or who need sponsorship for work authorization now or in the future, are not eligible for hire.
It is the policy of QuVa Pharma to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.