
emma camacho
manufacturing specialist
About
Experienced Manufacturing with a demonstrated history of working in the biotechnology industry. Skilled in Good Laboratory Practice (GLP), Analytical Skills, Change Control, GxP, and Quality Management. Strong operations professional with a Bachelor's degree focused in Microbiology, General from Universidad Interamericana.
united states
grovetown
pharmaceuticals
capa, software documentation, sop, quality assurance, validation, manufacturing, auditing, analysis, technical writing, training, process improvement, quality management, fda, gmp, 21 cfr part 11, trackwise, change control, quality system, cleaning validation, lims, glp, gxp, pharmaceutical industry, aseptic processing, gamp, quality auditing, regulatory affairs, regulatory requirements, computer system validation, regulatory submissions, technology transfer
Experience

qa coordinator
pharmaserv gmbh & co. kg

qa system specialist
schering-plough products

manufacturing specialist
echo consulting group

manufacturing assistant supervisor
mylan

manufacturing supervisor
mylan
* Responsible for motivating, training and development of personnel under his/her supervision: work performance, scheduling and task coordination; equipment and area preparation; complying with formula requirements. * Supervises personnel in production operations to assure control, adherence to safety, quality, and schedule requirements. * Created production schedule with the help of production reports. * Handled problems related to production by giving corrective action for quality problems. * Submitted production report to management on daily basis. * Understand specifications and job orders. * Resolve and analyze work related problems. * Set up and adjust work procedures to meet production schedules. * Administer personnel policies and procedures * Manage Team of more than 30 employees across the Manufacturing process * Organizing and planning staff shift rotes and tasks.

qa compliance coordinator
alza corp j&j vacaville
* Provided support to different areas in the use of TrackWise System. * Participated and helped Investigators develop Investigation Plans for investigations. * Responsible to prepare outstanding investigation. * Involved in the thorough preparation and approval of calibration investigation from the Engineering Department.

qa compliance coordinator
alza corp j&j
* Provided support to different areas in the use of TrackWise System. * Participated and helped Investigators develop Investigation Plans for investigations. * Responsible to prepare outstanding investigation. * Involved in the thorough preparation and approval of calibration investigation from the Engineering Department.
qa professional
gsk
* Implemented effective Deviations/Investigations and corrective/Preventive Actions (CAPA) processes at the site. * Participated and helped Investigators develop Investigation Plans for investigations. * Reviewed and approved Minor, Major and Critical deviations, corrective/preventive actions (CAPA’s) from Minor, Major and Critical deviations. * Approved reports as required, by Quality Management. * Developed and participated in audits, self-inspections of procedures, activities and documentation. * Assured harmonization of related SOP’s (process investigations) vs. current practices. * Kept regulatory expectations and trends. * Used risk management techniques to aid in assignment of priorities and quality assessment.

qa capa reviewer
mylan
* Participated and helped Investigators develop Investigation Plans for investigations. * Reviewed and approved Level 1, and, corrective/preventive actions (CAPA’s) from deviations. * Kept regulatory expectations and trends. * Used risk management techniques to aid in assignment of priorities and quality assessment. * Provided support to different areas in the use of TrackWise System.

manufacturing specialist
amgen
Education
universidad del turabo, gurabo
environmental science
universidad interamericana
microbiology
emma camacho's Contact Information
Phone
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