14297191
Located in Easthampton, MA
Pay: $52,827-$69,200/yr
Job Full Description
Express Employment is currently looking for a Senior Quality Associate for our client in Easthampton, MA
- $52,827-69,200/yr
- Full Time
- Long Term
- Day Shift Monday-Friday
- Direct Hire Position
Job Overview:
The Senior Quality Associate is part of a diverse team responsible for implementation and maintenance of Overlook’s Quality System. Supports all Quality activities and functions. The Quality Department controls a wide range of Overlook’s systems, including the Equipment, Documentation, Vendor and Training Programs.
Job Details:
- Review and approve forms related to routine activities such as incoming inspection of raw materials, facility cleaning and preventative maintenance of equipment.
- Reviews and approves Standard Operating Procedures (SOP).
- Reviews and approves quality events including non-conformances, change control and corrective/preventative actions.
- Lead CAPA, complaint and Nonconformance investigations and write/produce associated reports
- Maintains, organizes and archives documents including manufacturing packages, SOP’s and executed job records.
- Reviews and approves manufacturing packages used for production including blueprints, routing sheets, and inspection logs.
- Releases manufacturing packages for production based on client purchase orders.
- Reviews and approves executed manufacturing packages to ensure the product was manufactured in accordance with blueprints and applicable SOP’s.
- Assists with internal and external audits
Job Requirements:
- Associate's Degree from two-year college in relevant field and 2-3 years prior Quality experience in cGMP or ISO 9001:2015 regulated company
- Bachelor's Degree (BS/BA) from four-year college or university in relevant field and 1-2 years prior Quality experience in cGMP or ISO 9001:2015 regulated company
- Strong knowledge of pharmaceutical manufacturing processes, computer and equipment validation, GMPs, and product/process validation.
- Ability to develop clear, concise, and timely oral and written reports.
- Proficient in Microsoft Word & Excel, PowerPoint, and Vision Plus
- Experience with laboratory environment, equipment and safety procedures.
- Commitment to excellence and high standards
If you are interested in this position, please apply and a member of our office staff will contact you shortly. You may also call 413-264-0043 to set up an interview.
Springfield, MA
3078
430 Main St.
Suite 108
Agawam, MA 01001
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