favorite this post Quality Assurance Specialist I, Full-Time, Salaried (Round Rock) hide this posting unhide

1304 West Industrial Blvd.

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compensation: Salary commensurate with skills and experience.
employment type: full-time

Quality Assurance Specialist I (Full-Time, Salaried)

If this posting is up, a position is still available and we are still accepting resumes.

Do you have a B.S. degree in Microbiology, other biological science or similar field? Do you want to do Quality Assurance at a growing, small sized, fast paced, family owned commercial laboratory with a professional work environment? If so, this position may be for you.

About the Company:
Microchem Laboratory is a commercial testing laboratory founded in 1988. It is located in Round Rock, Texas. The lab specializes in the testing of antimicrobial agents, cosmetics, and medical devices. When this position is filled there will be approximately 40 people working at the company.

About the Position:
This is a GLP Quality Assurance position as defined in 21 CFR Part 58.35 and 40 CFR Part 160.35. Approximately 35% of time is spent in the laboratory doing GLP or ISO quality assurance inspections (e.g. procedural/test in-phase inspections and facility inspections). Approximately 65% of time is spent doing quality assurance desk work (e.g. final report audits and facility record audits).

Lab Hours:
Monday through Friday, 8:00 AM to 5:00 PM. Some early or later hours, overtime and weekends, as needed.

About the Interview Process:
A proficiency test may be given for detail orientation.

Required Qualifications:
• B.S. in a Biological Science.
• Excellent writing and review skills.
• Supreme, consistent attention to detail.
• Provide excellent, dependable customer service.
• Maintain a positive attitude.
• Ability to be a self-starter and work cooperatively with others in a small-company environment.

Desired Qualifications:
• B.S. in Microbiology.
• Prior experience as QA for a GLP testing lab.
• Knowledge of, and experience with EPA/FDA Good Laboratory Practice (GLP) regulations.
• Experience testing disinfectants or other antimicrobial agents.
• Experience performing preservative efficacy tests.
• Prior experience working as a scientist in a commercial testing lab.
• Deep technical knowledge of microbiology theory and practice.
• Experience in the safe handling of pathogenic microorganisms.
• Proficiency in Thunderbird and Libre Office, especially Calc and Writer.

Major Duties:
• Generally monitor each GLP or ISO compliant study to assure Management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations.
• Conduct an in-phase inspection of each GLP Study and maintain written and properly signed records of each inspection.
• Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation.
• Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the study.
• Prepare and sign a statement to be included with the final study report which shall specify the date(s) inspection(s) were made and findings reported to Management and to the Study Director.
• Maintain the GLP Master Schedule.
• Maintain copies of all protocols pertaining to all studies for which the unit is responsible.
• Conduct quarterly facility inspections and report findings to Management.
• Submit to Management quarterly status reports.
• Work with Management to implement and improve QA process efficiency.
• Interact with EPA/FDA as needed in the event of external (regulatory agency) audit.
• Write or review Standard Operating Procedures (SOPs).
• Maintain and improve lab documents and record keeping procedures.
• Interact directly with customers via phone, email and in person.
• Review protocols, experimental datasheets and reports.
• Assist with basic laboratory needs, such as cleaning, organization, or equipment validation.
• Maintain and improve lab documents and record keeping procedures.
• Assist with sales and marketing efforts as needed.
• Interact with and provide detailed and accurate information to accounting personnel.
• Maintain a safe, fast-paced, and positive laboratory environment.
• Other duties, as assigned.

Excellent, Comprehensive Compensation and Benefits:
• Salary commensurate with skills and experience.
• Paid vacation, sick time and company holidays.
• Company sponsored health insurance benefits and retirement savings plans.

To Apply:
Respond to this posting via Craigslist. Attach your resume and make the subject line of the email the words "QA Specialist I" then your name and a one-word description of your best professional attribute. Please do not call the laboratory. Someone from the lab will contact you if more information or an interview is desired.
  • Principals only. Recruiters, please don't contact this job poster.
  • do NOT contact us with unsolicited services or offers

post id: 6780359650


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