QA Specialist

Job Title: QA Specialist
Location: Indianapolis, IN 46221
Duration: 12 months+ (possible extension)
 
Duties and Responsibilities:

• Accurately count and prepare packaging supplies to ensure precise accountabilities before and after job orders.
• Assist Quality Assurance personnel and Production Supervisors, and approve components as required.
• Independently approve pharmaceutical products and in-process products at various stations.
• Review batch paperwork and follow supervisor instructions to perform necessary packaging procedures for each study.
• Complete AQLs (Acceptable Quality Limits) and handle line clearance responsibilities.

• Main business group.
• Reason for new request.
• Sourcing model.
• Training schedule.
• Possibility of conversion.

• High School Diploma.
• 0+ years of experience.
• General Pharmaceutical field experience.

• Documentation practices.
• Must understand GMP’s and GXP’s.
• Ability to read, write, and perform basic mathematics calculations.
• Strong hand-eye coordination, manual and finger dexterity, mindfulness, and the ability to perform repetitive tasks and learn new ones with assistance.
• Dexterity and ability to perform various manufacturing/packaging operations.
• Able to work 3 out of the 4 weekends.

• Conduct Pre-Post and AQL checks for Operations.
• Business casual for first few days and then will be provided a uniform. Will have a gowning procedure and need to wear that during core hours of work.
• NO Jewelry allowed other than wedding ring, (no facial piercings, earrings, necklaces, etc.)
• Will go through a vision Screening.
• Ability to stand for extended periods while working in rooms.
• Ability to exert up to 25 lbs. of force occasionally and/or 10 to 25 lbs. of force frequently to move objects.
• Ability to wear Personal Protective Equipment (PPE) such as respirators and protective eyewear as required.
• No allergies to specific drugs that would disqualify individuals from performing these duties.
• Near Vision Acuity of at least 20/40 with corrected vision, color vision, and the ability to adjust focus.

• Monday to Friday 6:30am to 3:15pm.
• Able to work 3 of the 4 weekends on overtime.

 
Business Group: Provide support for Packaging Operations
Reason for opening (new workload, backfill, LOA?): Increased Workload
Sourcing (direct send, resume review, regular?): MS Team interview (1-1 hour interviews)
How long is new-hire orientation?: OTJ Training, paired with team member until able to work independently
Do they need to train on another shift: Training on day shift for 2 weeks then go to their shift
Extension or conversion?: Temp for Now.