QA Specialist

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.
• Conduct Pre-Post and AQL checks for Operations.

Business Needs:

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

Culture and Expectations:

• Dress Code: Business casual for first few days and then will be provided a uniform.
• Site Providing.
• Equipment Requirements.
• Work Environment.
• Team Structure.
• Day to Day: Will have a gowning procedure and need to wear that during core hours of work.

Required Education:

• High School Diploma.

Required Experience:

• 0+ years of experience.
• General Pharmaceutical field experience.
• Documentation practices.
• Must understand GMP’s and GXP’s.

Requirements & Physical Abilities:

• No jewellery 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.
• 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.

Possibility of Conversion:

• Business Group: Provide support for Packaging Operations.
• 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.