Job Number: 21260353
- The Operator I is responsible for executing production activities required to successfully manufacture sterile injectable products.
- This is accomplished by ensuring equipment, materials, and other resources are in place to meet production demands.
- The Operator I demonstrate and assures production activities within manufacturing operations are executed following all GMP's.
- In addition, work will be performed in complete accordance with all SOPs, Specifications, Batch Records, regulatory expectations, and company policies.
- Accomplishes manufacturing activities per detailed procedural guidance with a demonstrated attention to detail.
- Performs handling of hazardous materials in compliance with site, industry, local, and federal regulations.
- Maintains manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.
- Executes specialized responsibilities mandated by detailed written procedures, site, industry, local, and federal regulations.
- Assures and completes detailed documentation that is a correct and accurate record.
- Addresses procedural /documentation errors expeditiously and effectively.
- Continuously updates job knowledge by participating in job specialized training requirements.
- Participates as a contributing member in CI projects.
- Consistently projects a positive attitude and example for other department team members/operators to emulate.
- Performs other tasks as assigned.
- High school diploma or equivalent required.
- 1 year of relevant work experience required, preferably in a regulated and/or pharmaceutical environment.
- An equivalent combination of education/experience may substitute.
- Robust functionality in Microsoft Applications and other computer-based systems utilized in the manufacturing department (i.E. MES, HMI's, etc.).
- Demonstrated proficiency in the ability to gown into applicable controlled areas per area classification specific requirements.
- Intermediate written and verbal communication skills within the department and with support groups.
- Functional job specific proficiency in mathematics.
- Practical understanding of specialized manufacturing equipment operational theory used for the manufacturing of sterile injectable products.
- Ability to pass a full physical including a respiratory certification with annual monitoring.
- Ability to stand up to 8 hours/day, utilizing controlled movements.
- Aptitude to use hand tools in the setup and troubleshooting of specialized manufacturing equipment.
- Ability to execute complex activities both independently and in a team environment.
- Full face respirator may be required for certain activities.
- The incumbent will be required to push, pull, reach, balance, and/or lift greater than 20 lbs. For 8 hours, approximately 5 times per week.
- The incumbent may be working around hazardous materials to include chemical agents at least 8 hours per day.
- The incumbent may be in a standing position for at least 8 hours per day.
- This position will require overtime, shift work, and flexibility in scheduling of " set shift hours at times, based on production demands or extraordinary circumstances.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Michael: mlanzaro@alphaconsulting.Com
ALPHA'S REQUIREMENT #22-02285
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE