Quality Assurance Batch Reviewer - Hauppauge, United States - LNK International, Inc.
Description
LNK International, Inc. is one of the nation's largest manufacturers of solid and liquid dose, over the counter (OTC) pharmaceuticals. For over 40 years, we have built a reputation for delivering the highest quality products, outstanding service and product innovation.
What sets LNK apart? We believe it is our employees. There is a commitment to quality in every department at LNK.
As a member of our Validation department you will be working with dedicated professionals who support and interact with all areas of the company.
Our full time employees enjoy competitive benefits including:
- 401(k) with generous employer match
- Health Insurance
- Dental Insurance
- Paid holidays
- Paid vacation
Shift:
Day Shift
This role reports to the Manager and is a key member of the QA team.
_Responsibilities_
Organize the records and coordinate activities related to Production/QA functions. Responsibilities include batch record/work order review, and releasing of batch records work orders for distribution.
Supports manufacturing/packaging activities pertaining to batch related documentation to support the timely production of finished goods to ensure compliance with cGMP and SOPs.
Organizes files and catalogues batch related documents for retrieval at a later time if needed.
Maintain records and organize documents to support packaging/manufacturing operations in an efficient manner.
This includes batch record/work order review including reconciliation of quantities for QA.
Assist when needed for any pertinent investigations involving respective.
Collect and use data to detect trends and improve.
Other duties or tasks may be assigned on an as-needed.
**_
Education/Experience_**High School diploma or higher
- Two years experience in a cGMP environment
- Good reading skills
- Has the ability to understand the production process and associated paperwork
- Good mathematical ability since checking of mathematical calculations is integral to the position.
- Must also be computer literate, proficient in cGMP's in a pharmaceutical setting and possess strong organizational skills in cataloging documents.
- The salary listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future. When determining a team member's base salary and/or rate, several factors may be considered as permitted by law.
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