QA Specialist
Job Description
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.
Business Needs:
- Main business group.
- Reason for new request.
- Sourcing model.
- Training schedule.
- Possibility of conversion.
Education and Experience:
- High School Diploma.
- 0+ years of experience.
- General Pharmaceutical field experience.
Knowledge, Skills and Abilities:
- 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.
Physical Demands / Work Environment:
- 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.
Interview: MS Team interview (1-1 hour interviews)