Work Schedule

12 hr shift/days

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Job Description

How will you make an impact?

The candidate will be responsible for the routine performance of operations in support of the manufacture of commercial and clinical biologics. These support activities consist of environmental cleaning and formulations of buffers and media per established standard operations procedures and in compliance with cGMP documentation practices.

Starting Wage is $21/hr + competitive benefits and bonus eligibility

Shift Information:

Rotating 12-hour Shifts, working 7 days out of a 2-week period.

Rotating 2 Weeks Example:

Week 1: Work Monday-Tuesday, Off Wednesday- Thursday, Work Friday-Sunday

Week 2: Off Monday-Tuesday, Work Wednesday-Thursday- Off Friday-Sunday

What you will do:

Preparing for and execution of manufacturing batch records, work instructions, and/or SOPs, with focus on safety and "right the first time" executions with minimal oversight.Weigh, Transfer, and Mix chemicalsDocumentation of all activities to meet cGMP requirements. Maintain cGMP compliance in assigned work and follow all safety procedures, to include the use of Person Protective Equipment.Complete preventative maintenance and work notification tasks on time. Equipment testing and routine troubleshooting of process and analytical equipment.Draft, review, and revise documents as needed.Run in-process analytical testing as required per the batch record..Maintain Raw Materials inventory through use of systems such as Kanban.Maintain up to date training recordsParticipate in other required activities (perform safety inspections, participate in improvement projects, etc.)Participate in shift exchanges, 1-1’s, meetings, attend meetings as needed to facilitate area needs based on changes, etc. (lean activities)

Education:

High school diploma or equivalent required.

Experience:Required: No previous work experience requiredPreferred: Previous work experience in manufacturing, operations, production or lab setting or related fieldPreferred: Experience in a cGMP environment

Knowledge, Skills, Abilities:

KnowledgeKnowledge of cGMP practices, aseptic techniques, or chemical concepts preferredSkillsStrong math skillsDetail orientedFocused on achieving outcomesMS OfficeAbilitiesAble to read, write, and communicate in EnglishAble to understand and carry out instructionsReliableEffectively multi-taskAdaptable to a multifaceted work environmentPossesses the ability to work both autonomously and collaboratively in a team environment.Physical Requirements / Work EnvironmentBe willing to wear a full gowning suit which includes: bodysuit, gloves, hair & beard nets, face covers, and safety glasses. (These items are prohibited: makeup, jewelry, nail polish, cologne / perfume, scented lotions or hair care products, etc.)Able to adhere to clean room gowning requirements, including wearing Tyvek, Nitrile, and/or Latex glovesAbility to lift minimum of 25 lbs independentlyAbility to stand for 80% of shift