Diatherix - Product QC Specialist

HudsonAlpha Huntsville, AL
This position is with Diatherix Eurofins Clinical Diagnostics which is located in the Hudson Alpha Institute, Huntsville, Alabama. Diatherix Eurofins Clinical Diagnostics is a highly-specialized laboratory providing cutting-edge molecular diagnostic testing services to hospitals and physicians using proprietary TEM-PCR (Target Enriched Multiplex Polymerase Chain Reaction) technology for precise detection of infectious diseases at high levels of sensitivity and specificity, and at very short turnaround times.

Qualifications: Bachelor's degree in chemistry or biology

Reports to: QC Manager

Supervision Required: This position requires direct supervision by the QC Manager.

General Description: The Product QC Specialist tests in-house produced reagents and new microarray source plate oligo synthesis prints, receives raw materials, follows current quality guidelines within the QC department, and participates in continual process improvements.

Specific Job Functions:

* QC tests in-house produced reagents and new microarray source plate oligo synthesis prints according to approved procedures.

* Receives and prepares paperwork for the release of raw materials for both Production and QC departments.

* Maintains records that demonstrate that QC testing is conducted according to approved procedures and assists with the preparation of product QC batch records.

* Is capable of identifying problems that may adversely affect reagent performance, can correct problems or immediately notify the supervisor, and documents all problems fully.

* Participates in job specific training and competency assessment reviews.

* Keeps workstations clean according to the cleaning policy.

* Observes all safety guidelines and wears personal protective equipment as necessary.

* Reports any quality deficiencies observed and makes suggestions for improving quality.

* Revises documents as requested by the supervisor according to current quality guidelines.

* Performs reagent stability testing according to approved procedures as applicable.

* Participate in small projects related to process improvements within the QC department.

* Assists with ordering and monthly inventory reports.

Additional Requirements Include:

* Demonstrated analytical data analysis/troubleshooting skills

* Highly organized & detail oriented with efficient time management skills. Daily tasks require self-management.

* Proficient in molecular biology techniques including pipetting, PCR, and aseptic techniques.

* Competent in utilizing Microsoft Office especially Excel use with macros, pivot tables, etc.

* Experience in writing/revising SOP documents.

* Strong presentation skills with ability to prepare/present a Microsoft PowerPoint presentation on a given topic.

* 1-2 years of research/manufacturing laboratory experience.