Amy Pedersen
Email: *********@********.***
Address: *** ******** *****
City: Camarillo
State: CA
Zip: 93012
Country: USA
Phone: 805-***-****
Skill Level: Management
Salary Range: $80,000
Primary Skills/Experience:
See Resume
Educational Background:
See Resume
Job History / Details:
Amy Jo Pedersen 411 Estancia Place Camarillo, CA 805-***-****
Objective:
To obtain a leadership position in a progressive, positive environment that challenges me by providing the opportunity to demonstrate my communication and technical skills while also allowing opportunity for growth and advancement.
Employment History:
11/07 12/10:
Baxter BioScience, Thousand Oaks CA 91320 Manufacturing Manager I, Packaging
08/04 11/07:
Baxter BioScience, Thousand Oaks CA 91320 Manufacturing Manager I, Production Services
11/01 08/04:
Baxter BioScience, Thousand Oaks CA 91320 Manufacturing Supervisor II
04/00 11/01
Baxter BioScience, Thousand Oaks CA 91320 Department Specialist, Quality Support
01/90 04/00
Procter and Gamble Oxnard CA 93030 Process Engineer Technician/Operations
Experience and Skills:
Evaluate standards, direct and ensure the timely of Final Container Recombinant for manufacture and release at the Thousand Oaks BioScience Facility. Including but not limited to oversight of:
Aseptic Sanitization Program oversight and investigations
Cleanroom Environmental monitoring overview and trend analysis, report and exception trending
Plan and direct special projects, multi budget management, cost projection and reduction.
Facility Shutdown and Startup Core Team Member
Participated in cross-facility projects to maintain and emphasize personal safety and company policy, including global interface, travel, facility and process evaluations.
Support and direct deviation and troubleshooting investigational teams and provide recommendations for improvements in processing and/or procedures.
Maintain control of employee relation issues and work with supervisors and Human Resources for resolution and improvement. Including management of multiple direct reports.
Knowledge and thorough understanding of SOPs and related paperwork with respect to the BioScience Manufacturing and Facilities. Knowledge of Regulatory Compliance and requirements, as well as auditing procedures and responses for internal or external parties.
Proactive in the development of all employees, including long-term goal realization.
Conduct staff meetings with supervisor and employees to discuss operational status within the facility and department in order to strengthen employee relationships, effective communication and provide input on department outputs towards goals and team unity.
.
Support or direct CAPA investigational teams and provide recommendations for improvements in processing and/or procedures.
Provide monthly report to Facility Directors reflecting the status of exception systems, organizational changes, environmental excursions, projects and budgeting.
Member of cross-functional QLP and CAPA teams.
Support provided to peers, supervisors and management as needed in a variety of areas, including daily schedules, interim reports, and identifying disciplinary issues and resolutions.
Additional Skills:
FDA and Global Regulatory trained, including host, response and interface.
Microsoft Word, Excel, Powerpoint
Trackwise
TeamCenter
Teambuilding/Organization
Presentations Creation and presenting
Organizational Leadership Skills
Education: Graduated Adolfo Camarillo High School
References: Available upon request.