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Apply online for the
Quality Compliance Associate
position and advance your career in the
Pharmaceutical industry today.
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Quality Compliance Associate : GlaxoSmithKline
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| Job Number |
73107 |
| Employee Type |
Full Time |
| Company Name |
GlaxoSmithKline |
| Location |
St. Louis
Missouri
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| Salary (year) |
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| Experience |
2 to 5 Years |
| Start Date |
1/18/2012 |
| Industry |
Pharmaceutical |
| Job Type |
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| Relocation |
Not Required |
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| Description |
Basic Qualification
• Bachelor of Science (or equivalent) degree
• Knowledge of FDA drug regulations, policies and guidelines
• 5 years experience in an FDA regulated environment
• Presentation skills
• Written and verbal communication skills
• Working knowledge of word processing, spreadsheet and database computer programs
• Basic statistical skills
• Self-starter
• Organization and follow-through skills
• Problem solving and troubleshooting skills
• Auditor certification, preferred
Details
The Quality Compliance Associate will be responsible for assisting with the site internal GMP auditing program, the site investigation/CAPA program, and the site GMP/SOP training program. This position is involved in most aspects of the QA team and learning the operation. Additional responsibilities include creating/co-creating the GMP training packets, final review/approval of batch records, assisting in investigations, assisting in meeting the department safety requirements and goals, and serve as back-up for various activities of the Quality Department management
• Participate in the site level 1 and level 2 Audit programs ensuring local compliance applicable federal, corporate and local policies and procedures; monitoring progress of CAPA
• Creating/co-create material and conduct required, annual, GMP training as well as new employee training
• Generating, manipulating and evaluating data for the Site’s Periodic Product Review Processes for all Value Streams
• Reviewing and assisting with investigations for the OOS and ATR Process
• Create, review, and/or revise the Quality Department SOPs.
• Assist and serve as backup to the Compliance Team Leader: Supporting the site Investigation program; communication of compliance and regulatory requirements; lead/participate on teams; coordination and completion of CAPA.
• Comply with site Safety and Quality policies and guidelines as well as all local and corporate policies and procedures. |
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| Requirements |
Preferred Qualification
Auditor certification, preferred
Experience working in a Quality role in an FDA regulated environment. |
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| Contact Info |
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Apply online at company website |
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