Ashley Bigenho Email & Phone Number

Salisbury, Maryland, United States

• Lead GMP compliance efforts to maintain and continuously improve site compliance.• Oversee operations of the Quality Unit related to Quality Systems Management, Stability Program, Internal/External Audits, Vendor Qualification, Document Control, Annual Product Quality Review, and Training.• Facilitate innovations and continual quality improvements, process improvements, non-conformance reduction, and enhancements to the Quality Systems, Stability Program, Data Review, Internal / External Audits, Vendor Qualification, Document Control, Annual Product Quality Review, and Training.• Oversee and compose Quality Control/Analytical documentation including Out-Of-Specification (OOS) Investigations, Out-Of-Trend (OOT) Investigations, and Out-Of-Routine (OOR) Release Investigations.• Review/approve Quality Systems documentation including deviations, change controls, CAPAs, Effectiveness Checks, and drug product complaints.• Review/approve Vendor Qualification documentation including Vendor and Service Provider Risk Assessments/Qualifications.• Oversee the procurement of consumables/services and negotiate contracts with vendors and suppliers.• Support readiness for regulatory inspections.• Support regulatory and client audits.• Manage daily workloads by organizing schedules and delegating tasks of the Compliance Team.• Facilitate team meetings and provide constructive feedback.• Monitor employee work to assess performance and identify knowledge gaps.

Salisbury, Maryland, United States

• Prepared technical reports summarizing findings from investigations or studies.• Ensured adherence to Good Manufacturing Practices GMP within laboratory environment.• Collaborated with cross-functional teams to address quality issues and implement corrective and preventive actions.• Updated standard operating procedures (SOPs) and Test Methods, as needed, for regulatory compliance and process improvements.• Monitored the sample submission, data compilation, and sample disposition processes.• Monitored instrumentation service contracts and inventory levels of laboratory supplies. • Negotiated contracts with vendors and suppliers and scheduled instrument service. • Monitored the QC training program.• Supported the QC department during internal and external audits.

Salisbury, Maryland, United States

• Analyzed raw materials, finished products, and in-process samples to ensure quality and conducted regular equipment maintenance checks to minimize downtime.• Recorded test results accurately and maintained well-organized documentation.• Interpreted data from various analytical instruments to make informed decisions about product quality.• Assisted QC management with composing investigation reports.• Assisted in process improvements.

Morgantown, Wv

• Performed analytical testing on solid dosage units (tablets and capsules) to ensure compliance with FDA and cGMP requirements according to approved written procedures and specifications.• Evaluated data in the QC laboratory to confirm the product(s) met requirements as per approved procedures, policies, and specifications, while maintaining established deadlines based on the business needs.• Ensured adherence to Good Manufacturing Practices GMP within laboratory environment.• Coached colleagues through instrumental issues, documentation review, and analytical testing, when necessary.• Participated in a 6s initiative within the QC laboratory.

Clarion, Pa

• Tutored about 12 students in the fields of chemistry and math. • Helped students understand chemistry and math concepts, organize notes, and prepare for tests.

Master Of Business Administration (Mba), Business Administration And Management, General

Activities and Societies: Member of Beta Gamma Sigma, Business Honor Society

Bachelor Of Science (Bs), Chemistry

Activities and Societies: American Chemical Society, Vice President and Treasurer of Delta Phi Epsilon SororityMath minor

Education record