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Description
POSITION SUMMARY
Using good GMP practices, is responsible for timely and accurate inspection and testing of incoming chemicals and analysis of in-process product components prior to the release to manufacturing, ensuring compliance with internal specifications. This position must prioritize to ensure schedule is met. Identifies and documents nonconforming materials and maintains trending of data. Provides technical writing skills as needed. In addition, position is responsible to ensure proper documentation according to cGMP's and current procedures. Performs all duties using safety conscious practices.
PRIMARY DUTIES
1. Inspects and tests incoming chemicals and in-process product components using analytical analysis and instrumentation (HPLC, UPLC, MS, LC/MS, UV-Vis, etc.).
2. Supports and executes protocols for analytical test methods and the ability to aid in the transfer of methods to Quality Control.
3. Identifies non-conforming material and documents conditions in Trackwise deviation system. Maintains / updates the material status of quarantined and non-conforming materials in the ERP/FTPS database.
4. Support product and process improvement, and engages in special projects as needed in QC and other areas.
5. Provides technical writing as needed; maintains trending and interpretation of KPI and other data as needed.
6. Updates procedures and/or specifications in the Document Control System; Performs Verification / Validations of scientific methods, systems, or equipment.
7. Manages and executes MT (micro-use) prepartions and scheduling activities for MT tests.
KNOWLEDGE, EXPERIENCE & SKILLS
1. Requires a 4-year degree in chemistry, biology or related scientific field.
2. Requires a minimum of 3 years related experience with proficiency in the use of analytical instrumentation.
3. Experience in a cGMP / FDA regulated environment is highly preferred.
4. Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
5. Must possess strong mathematical and analytical skills.
6. Must be able to demonstrate flexibility in responding to unexpected demands. Must also be able to work in team environment, building effective working relationships.
WORKING CONDITIONS
Domestic travel requires 10% of time
International travel required <5>
BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics' application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).
Description
POSITION SUMMARY
Using good GMP practices, is responsible for timely and accurate inspection and testing of incoming chemicals and analysis of in-process product components prior to the release to manufacturing, ensuring compliance with internal specifications. This position must prioritize to ensure schedule is met. Identifies and documents nonconforming materials and maintains trending of data. Provides technical writing skills as needed. In addition, position is responsible to ensure proper documentation according to cGMP's and current procedures. Performs all duties using safety conscious practices.
PRIMARY DUTIES
1. Inspects and tests incoming chemicals and in-process product components using analytical analysis and instrumentation (HPLC, UPLC, MS, LC/MS, UV-Vis, etc.).
2. Supports and executes protocols for analytical test methods and the ability to aid in the transfer of methods to Quality Control.
3. Identifies non-conforming material and documents conditions in Trackwise deviation system. Maintains / updates the material status of quarantined and non-conforming materials in the ERP/FTPS database.
4. Support product and process improvement, and engages in special projects as needed in QC and other areas.
5. Provides technical writing as needed; maintains trending and interpretation of KPI and other data as needed.
6. Updates procedures and/or specifications in the Document Control System; Performs Verification / Validations of scientific methods, systems, or equipment.
7. Manages and executes MT (micro-use) prepartions and scheduling activities for MT tests.
KNOWLEDGE, EXPERIENCE & SKILLS
1. Requires a 4-year degree in chemistry, biology or related scientific field.
2. Requires a minimum of 3 years related experience with proficiency in the use of analytical instrumentation.
3. Experience in a cGMP / FDA regulated environment is highly preferred.
4. Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
5. Must possess strong mathematical and analytical skills.
6. Must be able to demonstrate flexibility in responding to unexpected demands. Must also be able to work in team environment, building effective working relationships.
WORKING CONDITIONS
Domestic travel requires 10% of time
International travel required <5>
BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics' application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).
