Manufacturing Associate- 2nd Shift
Hours | Full-time, Part-time |
---|---|
Location | Lee, Massachusetts |
About this job
Job Description
Job Description
(Sun-Tue) 2:30pm- 2:00am
(Wed - Fri) 2:30pm - 2:00am
10% SHIFT DIFFERENTIAL
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
(Sun-Tue) 2:30pm- 2:00am
(Wed - Fri) 2:30pm - 2:00am
10% SHIFT DIFFERENTIAL
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Full-time Jobs Part-time Jobs Gig Jobs Posting ID: 933293619 Posted: 2024-05-06 Job Title: Manufacture Associate