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Quality Assurance Representative

3 months ago

Fremont, United States Ledgent Technology Full time

Quality Assurance Representative - Hybrid

Location: Hybrid in Fremont

Duration: 12+ month, Contract, W-2

Pay: $26.66/hr. - $30.00/hr

Duties:

· Conducts routine and non-routine analysis, including but not limited to biochemical and chemical analysis, of raw materials, in-process items and finished product according to established operating procedures.

· Compiles data for documentation of test procedures that may include stability program testing and formulation studies.

· Calibrates and maintains lab and analytical equipment.

· Participates in the preparation of investigations, summaries and reports.

· Reviews data obtained for compliance to specifications and reports abnormalities.

· Revises and updates standard operating procedures as needed.

· May perform special projects on analytical and instrument problem solving.

· May develop testing and analysis methods and procedures in accordance with established guidelines.

Skills:

* Review and determine reportability of complaints to FDA and international regulatory authorities.

* Write, review, and file Medical Device Reports (MDRs) and international Vigilance Reports.

* Works closely with Sales Representatives and health care professionals to obtain additional information.

* Monitor quality, completeness and timeliness of complaint investigations.

* Write customer response letters.

Qualifications:

* High School Diploma required

* 2+ years' QA or regulatory affairs, highly preferred

* Medical device or pharmaceutical experience highly preferred

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. To the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.