emma camacho

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.

Country

united states

City

grovetown

Industry

pharmaceuticals

Skill

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

pharmaserv gmbh & co. kg

qa coordinator

pharmaserv gmbh & co. kg

2008-1 - 2008-1 · 1 mo
schering-plough products

qa system specialist

schering-plough products

2003-1 - 2006-1 · 3 yrs 1 mo
echo consulting group

manufacturing specialist

echo consulting group

2015-2 - Present · 11 yrs 8 mos
mylan

manufacturing assistant supervisor

mylan

2010-1 - 2011-2 · 1 yr 2 mos
mylan

manufacturing supervisor

mylan

2011-3 - 2015-2 · 4 yrs

* 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.

alza corp j&j vacaville

qa compliance coordinator

alza corp j&j vacaville

2008-3 - 2008-6 · 4 mos

* 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.

alza corp j&j

qa compliance coordinator

alza corp j&j

2008-1 - 2008-1 · 1 mo

* 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.

gsk

qa professional

gsk

2006-1 - 2007-1 · 1 yr 1 mo

* 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.

mylan

qa capa reviewer

mylan

2010-1 - 2011-1 · 1 yr 1 mo

* 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.

amgen

manufacturing specialist

amgen

2015-2 - Present · 11 yrs 8 mos

Education

universidad del turabo, gurabo

universidad del turabo, gurabo

environmental science

universidad interamericana

universidad interamericana

microbiology

1993-1 - 2000-1 · 7 yrs 1 mo

emma camacho's Contact Information

Email

******@***.com

Phone

(**) *** ****

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