Location: Juncos, PR
Pay Rate: $23.73 / Hourly

Summary: Under limited supervision, performs manufacturing processes according to Standard Operating Procedures.

Functions:

• Must be proficient at Associate Manufacturing and may perform those functions in addition.
• Schedule operations.
• Perform initial review of manufacturing procedures/batch records.
• Train Mfg Operators and Associate Manufacturing on process theory.
• Draft and revise more complex documents (e.g. MPs, SOPs, technical reports, validation documents, investigation reports, etc.)
• Audit critical records.
• Propose corrective action for Quality incidents.
• Assist, & plan improvement implementation related to routine functions.
• Interact with other departments to implement planned improvements.
• Identify and propose solutions to complex problems.
• Perform data analysis (e.g., SPC, CPV) of critical process parameters.
• Lead capacity for equipment/process operations.
• May assist with recruiting effort May supervise staff.
• May perform system owner responsibilities (i.e., process, document).
• May interact with Process Development.**
• Other functions may be assigned.

Education/ Licenses:

• High school/GED + 4 years of directly related work experience or Associates + 2 years of directly related work experience or Bachelor degree in Sciences + 6 months of directly related work experience or Master's.

Competencies/Skills:

• Mechanical ability/expertise.
• Understand equipment/processes which leads to greater independent judgment.
• Basic statistical mathematical skills.
• Technical writing capability.
• GMP knowledge with ability to interpret & apply
• Interaction (seek outside resources as needed).
• Understand analytical methods for manufacturing area.
• Specific system/equipment skills.
• Basic project management skills. 
• Knowledgeable on MS Office 365
• PDF rendition.
• Veeva for document management.
• Knowledge on the following process: Deviation, Corrective Actions, Preventive Actions, Applicability.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 23.73/hr.