Formulation and Fill Technician II - 2nd Shift

Sun Pharmaceutical Industries; Billerica (MA); On-site; USD 50,000 - 70,000; Full time

Job summary

JobRx, Inc. in Massachusetts is seeking a Manufacturing Associate for the second shift (1:30 PM–10:00 PM EST). The role involves formulation and dispensing pharmaceutical products in a clean room environment in compliance with cGMPs and SOPs.

You will operate automatic and manual manufacturing processes, maintain equipment, document data, review batch records, and ensure quality and regulatory adherence while working in a controlled lab setting with exposure to syringes and needles.

Qualifications

• High School Diploma or GED required.
• Education in Life sciences or technical discipline preferred.
• Good organizational and record keeping skills.
• Basic computer skills.
• Attention to detail.
• Strong verbal, written and interpersonal communication skills.
• Familiarity with SOPs, Master Batch Records, and adherence to cGMPs preferred.
• Familiarity with aseptic fill/finish, formulation techniques preferred.
• Related experience in pharmaceutical environment preferred.

Responsibilities

• Formulate and dispense product in a clean room environment for Radio-pharm as well as dermatological products.
• Wash and sterilize all equipment, tubing, filters, stoppers, vessels, vials, ampoules etc.
• Perform all automatic and manual manufacturing processes as needed.
• Perform all required cleaning of manufacturing facility and equipment as needed.
• Follow all company policies relating to job safety.
• Perform preparation and set-up of glassware and lab equipment to ensure proper conditions for production process.
• Document data and review completed batch records to ensure product is made in accordance with specifications.
• Assist in review of SOPs and batch records, as needed.
• Perform equipment monitoring, under direction, as needed.
• Complete all necessary paperwork to conform with FDA regulations.
• Other duties as assigned.

Skills

Attention to detail

Organizational skills

Record keeping

Verbal communication

Written communication

Interpersonal skills

Basic computer skills

SOPs/cGMP familiarity

Education

High School Diploma or GED

Life sciences or technical discipline preferred

Job description

Job Summary

This role is for second shift 1:30PM-10PM EST. Performs the formulation and dispensing of pharmaceutical products according to current Good Manufacturing Practices (cGMPs) and utilizing Standard Operating Procedures (SOPs) in a clean room environment.

Area Of Responsibility

• Formulate and dispense product in a clean room environment for Radio-pharm as well as dermatological products
• Wash and sterilize all equipment, tubing, filters, stoppers, vessels, vials, ampoules etc.
• Perform all automatic and manual manufacturing processes as needed
• Perform all required cleaning of manufacturing facility and equipment as needed
• Follow all company policies relating to job safety
• Perform preparation and set-up of glassware and lab equipment to ensure proper conditions for production process
• Document data and review completed batch records to ensure product is made in accordance with specifications
• Assist in review of SOPs and batch records, as needed
• Perform equipment monitoring, under direction, as needed
• Complete all necessary paperwork to conform with FDA regulations
• Other duties as assigned

Work Conditions

• Office
• Lab
• Controlled areas
• Exposure to syringes and needles

Physical Requirements

• Stand, walk, sit, use hands and fingers to handle or feel, reach or push with hands and arms, stoop, kneel, crouch or crawl,
• Talk/hear
• Close vision, color vision, peripheral vision, depth perception, ability to focus
• Ability to visually inspect small products and print
• Operate lab equipment
• Operate computers/office machines
• Must wear lab coat and other safety attire
• Lift up to 50 lbs.

Travel Estimate

Up to 0%

Education and Job Qualification

• High School Diploma or GED required
• Work under direct supervision and follow clearly described procedures
• Education in Life sciences or technical discipline experience preferred
• Good organizational and record keeping skills
• Basic computer skills
• Attention to detail
• Strong verbal, written and interpersonal communication skills
• Ability to visually inspection small products/print

Experience

• Minimum of 2 - 5 years related experience preferred

• Familiarity with, and the ability to follow established Standard Operating Procedures (SOPs), Master Batch Records, and adhere consistently to current Good Manufacturing Practices (cGMPs) preferred

• Basic math, computer, and record keeping skills required
• cGMP training a plus

• Familiarity with aseptic fill/finish, formulation techniques preferred
• Experience working in a controlled environment preferred
• Related experience in pharmaceutical environment preferred