Analysis Skills, Change Control, Code of Federal Regulations, Communication Skills, Current Good Manufacturing Practice (cGMP), Dental Insurance, Detail Oriented, English Language, FDA Requirements, Manufacturing, Manufacturing Audit, Manufacturing/Industrial Processes, Multitasking, Organizational Skills, Presentation/Verbal Skills, Quality Assurance, Quality Management, Root Cause Analysis, Standard Operating Procedures (SOP), Team Player, Time Management, Vision Plan, Writing Skills
Job Summary:<\/b>
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The Quality Assurance Specialist is responsible for developing, implementing, and maintaining a cGMP Quality System to meet the requirements of 21CFR210, 21CFR211, Regulatory Agencies, and customer expectations.
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Duties/Responsibilities:<\/b>
<\/div>- · Review and approve/reject all raw materials and packaging components.
<\/li> - · Respond to customer complaints.
<\/li> - · Administer/review complaint investigations.
<\/li> - · Review all investigations as necessary.
<\/li> - · Create change controls.
<\/li> - · Revise all packaging and manufacturing batch records.
<\/li> - · Review and approve monographs, specification sheets, and analysis sheets.
<\/li> - · Handle all quarantine shipments.
<\/li> - · Audit manufacturing processes.
<\/li> - · Review and approve new labeling.
<\/li> - · Coordinate recalls.
<\/li> - · Review warehouse temperature monitoring data and charts.
<\/li> - · Support and provide assistance to the Quality Assurance Manager as necessary.
<\/li> - · Perform investigations, determine root cause, and develop CAPAs
<\/li><\/ul>Required Skills/Abilities:<\/b>
<\/p>- · Excellent verbal and written communication skills in English.
<\/li> - · Excellent management and teamwork skills.
<\/li> - · Excellent organizational skills and attention to detail.
<\/li> - · Excellent time management skills with a proven ability to meet deadlines.
<\/li> - · Ability to function well in a high -paced and at times stressful environment.
<\/li> - · Ability to understand and follow all Standard Operating Procedures and current Good Manufacturing Practices provided by the Company.
<\/li> - · Understanding of quality systems including change control, deviations and CAPAs.
<\/li> - · Ability to handle multiple tasks concurrently and complete them in a timely manner.
<\/li> - · Strong written and verbal language skills to effectively read and write SOPs and related lab reports, and communicate with personnel at all levels in the organization.
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Requirements<\/h3>
Education and Experience<\/b>
<\/p>- · B.S. in Chemistry, Biology, or equivalent work experience in a related field.<\/b>
<\/b><\/li> - · Experience in computer software, such as Microsoft applications.<\/b>
<\/b><\/li> - · Expert knowledge of cGMP regulations.<\/b>
<\/b><\/li> - · Expert knowledge and understanding of FDA policies and regulations.<\/b>
<\/b><\/li> - · Pharmaceutical experience required.<\/b>
<\/li><\/ul>Job Type: Full -time<\/b>
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Pay: $58,000.00 - $62,000.00 per year
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Ability to commute/relocate:
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- Gulfport, MS 39501: Reliably commute or planning to relocate before starting work (Required)<\/b>
<\/li><\/ul>Education:
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- Bachelor's (Preferred)
<\/li><\/ul>Experience:
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- Quality assurance: 3 years<\/b>
<\/li> - Pharmaceutical Investigations: 3 years <\/b>
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Benefits<\/h3>
Benefits:<\/b>
<\/p>- Dental insurance
<\/li> - Health insurance
<\/li> - Life insurance
<\/li> - Paid time off
<\/li> - Vision insurance
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