43 QA Specialist I Jobs in Austin, TX
Collins Consulting is Hiring a QA Specialist I Near Austin, TX
Individual will work in the client's global quality organization processing pharmaceutical, medical device and combination product complaints and inquiries. Interface with internal the client's customers such as physicians, nurses, pharmacists, hospital personnel, risk managers, purchasing agents, sales representatives, general public, manufacturing sites, technical support, commercial organization and PV regarding the client product complaints. Responsible for product complaint documentation, investigations and identification of potential adverse events and potentially reportable events. Responsibilities may include creation and submission of regulatory reports, creation of customer communications and interface with various third parties.
Responsibilities"Assure complaint records meet global requirements.
"Product complaint documentation, investigation, and review of all non-medical complaint content. Responsible for reviewing Medical complaints that involve a non-medical quality related problem. Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product.
"Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GCP. This requires good analytical skills, technical writing and good documentation. Responsible that complaint files meet all regulatory requirements.
"Identification of potentially reportable events and notification to appropriate functional groups and management.
"Interface with Third Party Manufacturers, health care professionals, general public, internal customers, the client's functional areas and regulatory agencies.
Qualifications"Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.
"Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.
"Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.
"Solid written/verbal communication and organizational skills.
"Knowledge and application of computer systems for word processing and complaint management.
"Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.
"A Bachelor Degree required. Preferred degree in technology or scientific background (MLT, LPN, RN).
"0-3 years work experience in a cGMP related industry or in a clinical setting is preferred
" 1 year quality and/or complaint handling experience.
What are the top 3-5 skills requirements should this person have?
" Detail oriented
" Microsoft Excel Knowledge and Experience sorting, filtering are a must
" Adaptive to change
" Self-starter/independent worker
" Taking initiative to improve/create efficiency
What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
" Degree is preferred
" 3-5 years quality and/or complaint handling experience. Degree in science, nursing, or equivalent.
Job Summary
Contractor
IT Outsourcing & Consulting
$64k-79k (estimate)
06/08/2024
07/06/2024
colcon.com
SCHAUMBURG, IL
200 - 500
1992
ROBERT COLLINS
$10M - $50M
IT Outsourcing & Consulting
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About Collins Consulting
Collins Consulting brings over two decades of total talent solutions experience to meet your on-demand consulting needs. We have an established history of serving clients nationwide in both the public and private industries. These clients range from Fortune 100 companies within the commercial arena to supporting contracts within federal agencies. Collins Consulting is a certified Service-Disabled Veteran Owned Small Business and an SBA Small Business. We believe in servicing our country's veterans by supporting and nurturing opportunities to join their skillsets with clients who have the same ...principles. These certifications coupled with Top Secret facility clearance allow us to meet category and diversity goals. Collins Consulting is agile, innovative, and an award-winning advocate in providing total talent solutions to serve your business needs. Whether you are a professional who is looking for a new career or an organization in need of experienced talent, we have the resources to help you.
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The job skills required for QA Specialist I include Customer Service, Initiative, Standard Operating Procedures, Verbal Communication, etc. Having related job skills and expertise will give you an advantage when applying to be a QA Specialist I. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by QA Specialist I. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for QA Specialist I positions, which can be used as a reference in future career path planning. As a QA Specialist I, it can be promoted into senior positions as a Quality Assurance Specialist II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary QA Specialist I. You can explore the career advancement for a QA Specialist I below and select your interested title to get hiring information.
If you are interested in becoming a QA Specialist, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a QA Specialist for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
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Step 3: View the best colleges and universities for QA Specialist.
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