Quality Assurance Specialist Job at Allen Spolden, Gulfport, MS

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  • Allen Spolden
  • Gulfport, MS

Job Description

Job Description
Job Summary:

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.

Duties/Responsibilities:

  • Review and approve/reject all raw materials and packaging components.
  • Respond to customer complaints.
  • Administer/review complaint investigations.
  • Review all investigations as necessary.
  • Create change controls.
  • Revise all packaging and manufacturing batch records.
  • Review and approve monographs, specification sheets, and analysis sheets.
  • Handle all quarantine shipments.
  • Audit manufacturing processes.
  • Review and approve new labeling.
  • Coordinate recalls.
  • Review warehouse temperature monitoring data and charts.
  • Support and provide assistance to the Quality Assurance Manager as necessary.
  • Perform investigations, determine root cause, and develop CAPAs
Required Skills/Abilities:

  • Excellent verbal and written communication skills in English.
  • Excellent management and teamwork skills.
  • Excellent organizational skills and attention to detail.
  • Excellent time management skills with a proven ability to meet deadlines.
  • Ability to function well in a high-paced and at times stressful environment.
  • Ability to understand and follow all Standard Operating Procedures and current Good Manufacturing Practices provided by the Company.
  • Understanding of quality systems including change control, deviations and CAPAs.
  • Ability to handle multiple tasks concurrently and complete them in a timely manner.
  • 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.

Requirements

Education and Experience

  • B.S. in Chemistry, Biology, or equivalent work experience in a related field.
  • •Experience in computer software, such as Microsoft applications.
  • •Expert knowledge of cGMP regulations.
  • •Expert knowledge and understanding of FDA policies and regulations.
  • •Pharmaceutical experience required.
Job Type: Full-time

Pay: $58,000.00 - $62,000.00 per year

Ability to commute/relocate:

  • Gulfport, MS 39501: Reliably commute or planning to relocate before starting work (Required)
Education:

  • Bachelor's (Preferred)
Experience:

  • Quality assurance: 3 years
  • Pharmaceutical Investigations: 3 years

Benefits

Benefits:

  • Dental insurance
  • Health insurance
  • Life insurance
  • Paid time off
  • Vision insurance

Job Tags

Full time, Work experience placement, Relocation,

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