MANUFACTURING PROCESS TECHNICIAN

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

Performs manufacturing processes according to Standard Operating Procedures.

Perform initial review of manufacturing procedures and batch records

Train Manufacturing Operators and Associate Manufacturing staff on process theory

Draft and revise complex documents (e.g., Manufacturing Procedures, SOPs, technical reports, validation documents, investigation reports)

Audit critical manufacturing records

Propose corrective actions for quality incidents

Assist in and plan improvement implementations related to routine functions

Collaborate with other departments to implement planned improvements

Identify and propose solutions to complex problems

Perform data analysis (e.g., SPC, CPV) on critical process parameters

Lead equipment and process operations

May perform system owner responsibilities (e.g., for process or documentation)

May collaborate with Process Development

When assigned to assist the Process Owner under supervision of a Manufacturing Specialist or Senior Manufacturing Specialist:

Support the generation and review of manufacturing procedures and related documentation

Troubleshoot processes and assess performance through process monitoring

Participate in the NC/CAPA process by performing process assessments, contributing to investigations, defining/implementing CAPAs, and reporting on incident trends

Assist in the generation, review, and execution of process validation protocols

Support new product introductions and product lifecycle activities

Initiate and implement Level 1 and Level 2 Change Control records

Qualifications:

High school/GED and 1 year of work experience

Mechanical aptitude and technical expertise

Understanding of equipment and manufacturing processes

Proficiency in statistical and mathematical analysis

Good knowledge of GMP and the ability to apply regulatory expectations

Understanding of analytical methods relevant to the manufacturing environment

Familiarity with specific manufacturing systems or equipment

Basic project management capabilities

Prior experience in GMP environments or basic computer proficiency is preferred

Must be proficient in Associate Manufacturing functions and may perform those duties as well.

PPE is provided onsite, and candidates must be comfortable working in a fast-paced, physically active environment.

Day shift (Monday–Friday, 9:00 AM to 5:30 PM) and is expected to transition to a second shift schedule after approximately four months, with shift differential applied.

After 4 months able to transition to evening shift (Mon–Thurs, 3:00 PM – 1:30 AM or 3:00 PM – 11:30 PM depending on business need)

CANDIDATES MUST BE WILLING TO TRANSFER TO THE SECOND OR NIGHT SHIFT