Janice Pinterics Email & Phone Number

Greater Salt Lake City Area

Key driver in leading the organization to achieve ISO 15189 accreditation. Influential leader dedicated to promoting standardization and creating a robust quality management system.

Greater Salt Lake City Area

Greater Salt Lake City Area

Review and approve laboratory investigations, equipment qualification protocols, methods, method transfers and validations. Author, review, and approve deviation investigations and corrective and preventive actions. Provide audit support (internal and external) as needed.

Performed in the cytogenetic laboratory that processed blood and bone marrow samples for analysis of chromosomal abnormalities via traditional karyotyping (Giemsa band staining); fluorescent in-situ hybridization (FISH) and comparative genomic hybridization.

Responsible for internal/external audits; supplier qualification program; annual product reviews; complaint handling; training; and deviation investigation and corrective and preventive action program. Responsible for international product lines and led team for global harmonization of annual product reviews. Successfully managed a number of critical compliance situations. Established a very positive working relationship with both domestic and international regulatory agencies. Active contributor to several corporate teams tasked with harmonization of global practices. Streamlined complaint handling and annual product review practices to allow existing staff to manage significant workload/product line increases without headcount increases.

Assumed responsibilities for annual product reviews. Upon assumption of these responsibilities, transformed the on-time compliance rate from 0% to 100% without additional resources and also significantly improved the quality of the documents.

Responsible for creating and developing a Quality Engineering Department. Activities included responsibility for final approval for all method validation protocols, equipment qualification protocols, facility qualification protocols, HVAC qualification protocols, and process validation protocols. Watson Quality representative for Corporate effort to harmonize equipment qualification practices.

Gained responsibilities for quality review of all qualification/validation and change control activity for site (commercial and development.)

Responsible for approval of all commercial change request documents. Chaired a change control review committee and re-organized the scope and purpose of the team. Review committee comprised of Management from Regulatory Affairs, Quality Control, Production Administration and Materials Management.

Reported to site Quality Head. Responsible for all technical product complaints, Material Evaluation Reports, Problem Analysis and Corrective Action Reports and Deviations. Implemented and evaluated the effectiveness of corrective and preventive actions. Closed all outstanding Deviations and Problem Analysis and Corrective Action Reports that had remained open since 1997-1999.

Responsible for the investigation of all technical product complaints and trending of all medical and technical complaints. Maintained an on time performance rate of 98% or greater for closure of all technical product complaints despite an increase in number from 300 technical product complaints in 1998 to 452 technical product complaints in 1999 without additional resources. Implemented several product improvements that effectively reduced the number of complaints generated for those complaints. Recipient of the Exceptional Yearly Employee Award in recognition of achievements accomplished throughout the year in support of the success of the company.

Supervised a team of 9 laboratory technicians in the fields of microbial preservative effectiveness testing, antibiotic assays, crystallinity, biological indicators, particulate testing, and growth promotion. Developed and implemented a training course on out of specification laboratory investigations and the handling of aberrant data. Maintained an on time performance of 97-100% for the release of stability samples, finished product samples, and raw material samples. Implemented assay improvements that led to a reduction in the void/retest rate.

Reviewed and prepared summaries of environmental monitoring results of aseptic and non-aseptic manufacturing areas. Performed a wide variety of quality control microbiological tests.

Master Of Public Health, Toxicology

Bachelor Of Science, Biology