Quality Assurance Inspector
US - Pennsylvania - Allentown Update time: October 14,2020
Job Description
When you are part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
How will you make an impact?
As part of our global team, what you do contributes directly to our mission; enabling our customers to make the world healthier, cleaner and safer.
*First Shift Position and Mandatory Overtime Required*
Education/Experience
Preferred Qualifications
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today! http://jobs.thermofisher.com
How will you make an impact?
As part of our global team, what you do contributes directly to our mission; enabling our customers to make the world healthier, cleaner and safer.
*First Shift Position and Mandatory Overtime Required*
Education/Experience
- Associate’s degree
- A minimum of 1 year of experience in Pharmaceutical or of a related, regulated industry and at least 2 years supervisory experience required
Preferred Qualifications
- Bachelor’s degree
- Proficient in Microsoft Office including Word, Excel, Access, and Outlook. Knowledge or prior experience with Current Good Manufacturing Practices (cGMP) for pharmaceutical products.
- Experience with Quality Systems (Change Control, deviations, complaint management, documentation management, among others).
- Applies Good Manufacturing Practices (cGMP) in all areas of responsibility.
- Demonstrates and promotes the company vision.
- Performs approval of specifications and incoming inspections on material (i.e. drug, components) and distribution shipments.
- Performs process inspections, samplings, and audits as required.
- Participates in continuous improvement initiatives and assists with root cause investigations for nonconforming issues.
- Author’s, revises, and complies with all relevant SOP’s and Work Instructions and properly documents activities when necessary.
- Follows all Thermo Fisher Standard Operating Procedures.
- Performs all activities in a safe and efficient manner.
- Assures that issues potentially affecting product quality/compliance are escalated to the attention of the Team Leader and/or Management.
- Assures that issues are resolved in a timely manner and corrective actions are implemented accordingly.
- Other duties may be assigned to meet business needs.
- Strong knowledge of quality system regulations/requirements (i.e. ISO 9001:2000, 21 CFR Part 211/ 210, Part 601/610, Part 1271, Part 820 and cGMP/GLP and USP, EPA regulations).
- Experience with wet chemistry techniques and operating lab equipment such as Balances, Ovens & Spectrophotometers.
- Analytical instrumentation basics required and hands-on experience desired for A/ICP, Auto-titrators, TOC, HPLC, GC, IR, XRF and CE.
- Strong in application of technical principles, practices and procedures.
- Effective communication skills at all levels both written and verbal.
- Effective skills in analytical thinking and problem solving.
- Ability to perform multiple tasks and ability to effectively manage conflict.
- Ability to work in teams to obtain results, self-motivated/directed, ability to organize activities, minimal supervision required.
- Proficiency in Microsoft Office, LIMS, and statistical programs (i.e. MiniTab).
- Must be able to work in a refrigerated environment (2ºC to 8ºC) with provided protective wear.
- Must be able to work in a freezer environment with provided protective wear.
- Must be able to work in potent compound suites with provided protective wear (PPE).
- Good reasoning and problem-solving skills, basic math skills, good communication skills, basic computer skills.
- Must be willing to work various shifts and overtime depending on business needs.
- Must be able to work independently.
- Must not be allergic to penicillin or cephalosporin products.
- Extensive standing and walking on packaging floor in order to monitor room activities.
- Work schedule, Monday through Friday, 7.5 hours per day. Additional overtime and weekend (Saturday or Sunday) work may be required.
- The employee must occasionally lift and/or move up to 20 pounds.
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today! http://jobs.thermofisher.com
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