Careers

Pharmaceutical Quality Specialist I - Monday - Friday / 7:00am - 4:30pm

    • Job Tracking ID: 512885-801164
    • Job Location: Des Moines , IA
    • Job Level: Any
    • Level of Education: BA/BS
    • Job Type: Full-Time/Regular
    • Date Updated: January 04, 2022
    • Years of Experience: Up to 2 Years
    • Starting Date: December 14, 2021
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Job Description:

Job Description:

The Quality Specialist I will provide QA support of manufacturing operations, analytical laboratory testing and materials management for Surmasis Pharmaceutical. This role is responsible for the review and evaluation of batch data, including batch records, deviations, in-process records, EM data, QC release testing and other quality systems documentation as needed in support of commercial product disposition.

 

Responsibilities:

? Provide Quality support and oversight of cGMP manufacturing, packaging, and analytical activities.

? Review/approve operational documentation including executed batch records, QC release testing, validation protocols, etc

? Participate in investigations and preparing Quality documentation such as deviations/non-conformance, out-of-specifications, complaints, Corrective Action/Preventive Action (CAPA) investigation

? Escalate critical and major findings to Quality management and monitor key performance indicators

? Assist in maintaining the Quality Management System, including preparing and performing change controls and creating, revising and implementing standard operating procedures

? Support site training activities and providing training for new employees.

? Perform environmental monitoring tasks and documentation review and reporting

? Provide Quality support for manufacturing activities

? Support in preparation of annual product quality reviews

? Assist in quality audits and regulatory inspections, as needed.

? May collect samples, prepare shipments and inspect raw materials and finished goods.

? Review raw material, finished goods and packaging release documents

? Investigate nonconformities

? Assist with maintaining supplier qualifications, and requesting supplier documents

? Communicates effectively with internal stakeholders and external partners and management

? Must work closely with cross functional teams (including Operations, R&D, Engineering and other quality groups.)

? Drives continuous improvement efforts regarding Quality Management System processes by identifying improvement opportunities and presenting solutions to the improvement opportunities.

Experience and Skills:

Qualifications:

? Degree in Biology, Microbiology, or related life sciences with 0-3 years of related experience preferred, or equivalent will be considered with relevant industry experience.

?Previous working knowledge of GMP Regulations and ICH Guidelines governing current Good Manufacturing Practices for Pharmaceuticals or other regulated industry is highly desired.

? Previous experience in Quality Assurance is desired.

? Ability to work cross-functionally with departments (Operations, Quality, Supply Chain, Project Management, and Engineering) and individuals at all levels

? Must be comfortable in a fast-paced environment with minimal direction and changing priorities

? Strong working knowledge of computer systems, electronic Quality Management Systems, MS Office, etc.

? Ability to communicate in a solution-focused manner, and keeping management aware of potential issues.

? Organized, detail oriented and ability to multi-task

? Ability to troubleshoot and resolve problems.

Benefits

Benefits: PPO/HMO Health, Dental, Vision, FSA, STD/LTD, Life option, 401(k)

PTO: 3 weeks/yr; @10 years - 4 weeks/yr

7 paid holidays including New Year, Memorial Day, 4th of July, Labor Day, Thursday & Friday for Thanksgiving and Christmas Day