765 Smithtown Bypass, Smithtown, NY - 11787 Hauppauge, NY 11725
Principal duties and responsibilities for this position include:
- Creates, reviews and revises all labeling materials to meet FDA Regulations and customer request.
- Research regulatory questions and consult for the department
- Creation of Packing Batch Records masters documents
- Creates initial AQL paperwork for each incoming lot of labels, and ensures the proper documents are attached.
- Creates Current Approved/ Customer Approved Master Label / IFC forms.
- Documents all incoming labeling receipts in log book.
- Daily Performance check on the Scan gun and documents results in log book.
- Inspects and release label components using AQL paperwork (Final Release).
- Releases staged packaging jobs, and properly store them in the assigned location.
- Blister Prints mat approvals
- Reconciles all packaging paperwork and notes if any corrections are needed.
- Maintains organized files of all approved proofs / customer approvals.
- Supplies monthly/ quarterly inventory of labels for customers.
- Assist in documenting returns on Inventory cards.
- Assist in counting labeling when needed.
- Label destruction / returns.
- Must have pharmaceutical experience, preferably in Regulatory and Labeling (2-5 years a must)
- Computer proficiency Word, Excel (2 + years a must)
- Strong verbal and written communication skills. (Report Writing) (Data Analysis).
- In-depth knowledge of cGMPs, FDA, CFR requirements, and general safety.
HW Staffing Solutions provides job seekers nationwide great direct hire, temporary and temporary to hire job opportunities with great employers. Find jobs in accounting & finance, office & administrative, light industrial, professional/technical, call center and food processing. Get personal attention, unrivaled benefits and a chance to grow your career.
Schadaxary (Schary) Belgaumkar
Senior Executive Recruiter
I have been working with HW Staffing Solutions for the past 2 1/2 years. I have extensive experience in light industrial positions, administrative & clerical positions. My passion is helping people find their ideal job!