Manufacturing Associate (All shifts)

Sharp Services, LLC; Lee, Northern (MA, KY); Hybrid; USD 40,000 - 73,000; Full time

Job summary

Sharp Services, LLC seeks a Manufacturing Associate for all shifts in Lee, MA to perform production operations in a GMP environment. You will support start-ups, changeovers, and tech transfer activities, and maintain strict documentation and training compliance.

The role requires ability to read and follow SOPs/BRs, participate in audits, and work a 24/7 shift schedule with proper safety and quality focus. Associates degree or equivalent experience preferred.

Qualifications

• Associates Degree or HS diploma with 0–2 years of related experience.
• Technical depth gained from professional experience may substitute for a degree.
• Experience reading SOPs and batch records is preferred.

Responsibilities

• Operate glass washers and autoclave.
• Prepare buffers, medias and other solutions following procedures.
• Operate process equipment and CIP/SIP systems as trained.
• Document activities and maintain GMP compliance.
• Support training and audit readiness.

Skills

GMP regulations knowledge

Documentation

Verbal & written communication

English reading & writing

Attention to detail

Education

Associates Degree or HS diploma with 0–2 years related experience

Tools

Microsoft Word

PowerPoint

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Manufacturing Associate (All shifts)

Full Time Manual Labor Lee, MA, US

30+ days ago Requisition ID: 1778

Salary Range: $19.00 To $35.00 Annually

Position Summary

Perform all production operations in the areas assigned within the facility. Perform production support operations in areas assigned and support start-up, changeovers and tech transfer activities.

Duties and Responsibilities

• Operate glass washers and autoclave
• Prepare buffers, medias and other solutions, following written procedures and batch records
• Operate process equipment such as tanks, clean in place skids (CIP/SIP), agitators, filtration devices, autoclaves, glass washers, integrity testing and other small equipment
• Perform process steps in coordination with other associates asking for help as needed so as not to perform steps without proper training/qualification
• Adhere to scheduling changes and responds appropriately
• Communicate with supervisor on issues regarding work orders or shifts in process parameters
• Give input and make suggestions to improve process
• Follow all GMP’s and EHS procedures
• Attend and completes all mandatory training
• Ensure training plan is accurate and up-to-date
• Complete all necessary documentation per the required GMP practices
• Participate in presenting the manufacturing areas in a state of audit readiness
• Perform production operations following written SOP’s/BR’s in accordance with GMPs
• Other duties as assigned

Regulatory Responsibilities

• Conduct business in a responsible manner that complies with all state, FDA, OSHA and HIPAA regulations, or otherwise as applicable

Supervisory Responsibilities

• N/A

Experience

• Experience in a GMP environment and in an approved laboratory under minimal supervision preferred

Education

• Associates Degree or High School Diploma with zero (0) to two (2) or more years of directly related experience.
• Degree in other discipline (or lack of degree) may be considered if sufficient technical depth has been achieved from professional experience

Knowledge, Skills & Abilities

• Understanding of the basic FDA cGMP regulations
• Verbal and written skills
• Basic software application skills (Word, Power Point)
• Able to follow detailed processing instruction
• Accurately document all necessary documentation
• Satisfactory audio-visual acuity
• Ability to read and write English
• Familiarization with technical issues in the area
• Ability to work shift that covers a 24/7 operation
• Ability to work shifts and off hours, as applicable

Physical Requirements

• Ability to sit or stand for prolonged periods of time
• Ability to lift and carry materials weighing as much as 50lbs