General Manufacturing Operator With Pharmaceutical GMP:
Alpha Consulting Corp.

Description

Project Description:

• 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.
• This position will require overtime, shift work, and flexibility in scheduling of "set shift hours at times, based on production demands or extraordinary circumstances.
• 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.

Required Skills:

• 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 hrs./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.

This 8+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Malika:

ALPHA'S REQUIREMENT #22-01277
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE