Aseptic Manufacturing Associate (Weekend Nights)

Grand River Aseptic Manufacturing Inc.; Grand Rapids (MI); In loco; USD 55.000 - 73.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical benefits

Dental & Vision insurance

Life insurance

Disability insurance

401(k) with company match

Paid volunteer time

Paid time off

Wellness time off

Paid holidays

Descrizione del lavoro

Grand River Aseptic Manufacturing Inc. in Grand Rapids, MI, is seeking an Aseptic Manufacturing Associate for weekend nights. The role supports aseptic filling, testing, documentation, and batch records within a regulated cGMP manufacturing environment.

You will work in Grade 5, ISO 6, ISO 7, and ISO 8 cleanrooms, under supervision, with gowning and qualification requirements. Benefits and shift-specific details are discussed during the interview process.

Competenze

• Bachelor's degree or high school diploma with 2+ years relevant work experience for Level I
• Bachelor's degree or high school diploma with 3+ years relevant work experience for Level II, plus sterile environment experience
• Bachelor's degree or high school diploma with 4+ years relevant work experience for Level III, plus sterile environment experience
• Qualification for use of a full-face respirator is required when working with hazardous chemicals
• PAPR is required for hazardous chemicals during chemical dispense and addition activities

Mansioni

• Perform equipment preparation, bulk drug formulation, and aseptic filling duties as needed
• Accurately document data and complete batch records as needed
• Perform cleaning and sanitization duties as instructed by the applicable procedure
• Successfully complete facility's aseptic gowning and manufacturing qualification program
• Perform duties in Grade 5, ISO 6, ISO 7, and ISO 8 cleanrooms

Conoscenze

Sterile manufacturing

Aseptic technique

cGMP knowledge

Documentation

Safety compliance

Formazione

Bachelor's degree or HS + 2–4 years experience

Sterile environment experience

Descrizione del lavoro

Aseptic Manufacturing Associate (Weekend Nights)

Agility, Impact, Methodology. Do you exhibit these values and wish to be around others that do too? Do you thrive in fast-paced environments where agility, adaptability, and high standards go hand in hand? Are you driven to make a meaningful impact, whether through your work, your support of others, or your commitment to your community? Are you motivated by a disciplined, science-based approach that ensures consistent excellence, safety, and integrity in everything you do?

Overview of this Position

The Aseptic Manufacturing Associate (AMA) is responsible for performing various routine manufacturing tasks following established procedures and cGMP regulations under guidance of a production supervisor and/or senior management.

This primary location for this role is at our Front Avenue facility. The hours are from 6:00 pm to 6:00 am on Friday, Saturday, and Sunday.

Non-Negotiable Requirements

• A bachelor's degree OR a high school diploma and 2+ years relevant work experience in a manufacturing, medical, and/or laboratory environment is required for a Level I role.
• A bachelor's degree OR a high school diploma and 3+ years relevant work experience in a manufacturing, medical, and/or laboratory environment is required for a Level II role. Must also have experience working in a sterile manufacturing environment.
• A bachelor's degree OR a high school diploma and 4+ years relevant work experience in a manufacturing, medical, and/or laboratory environment is required for a Level III role. Must also have experience working in a sterile manufacturing environment.
• Qualification for use of a full-face respirator is required when working with hazardous chemicals.
• PAPR is required for working with hazardous chemicals during chemical dispense and addition activities.

Preferred Requirements

• Previous experience in pharmaceutical manufacturing or a laboratory environment is preferred.

Responsibilities Include

• Perform equipment preparation, bulk drug formulation, and aseptic filling duties as needed.
• Accurately document data and complete batch records as needed.
• Perform cleaning and sanitization duties as instructed by the applicable procedure.
• Successfully complete facility's aseptic gowning and manufacturing qualification program.
• Perform duties in Grade 5, ISO 6, ISO 7, and ISO 8 cleanrooms.

Full job description available during formal interview process.

Benefits

• BENEFITS starting day 1: Medical, prescription, dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying a portion of the cost! Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well. We also offer generous off-shift premiums!
• Paid VOLUNTEERISM starting day 1: GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!
• PAID TIME OFF: You choose how to use this time for your vacation, sick, or mental health needs! PTO: Full-time employees accrue up to 104 hours of paid time off per calendar year, with this amount being prorated your first year. WELLNESS TIME OFF (WTO): In addition to PTO, employees earn 1 hour of wellness time off for every 30 hours worked, to use how you choose.
• PAID HOLIDAYS: We offer 10 paid holidays per calendar year with immediate eligibility!
• PAY: Depends on Experience and is discussed during the interview process.