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Online Resumes with "Capa"



Chemist - 15 Years of Experience - Near 07747

SUMMARY OF FUNCTIONAL EXPERIENCE AT AKORN: Hands-on experience with pharmaceutical analysis using HPLC, GC/HS, Spectroscopy, physical and wet chemistry. Familiarity with Analytical Chromatography software Backman Peak-Pro, Perkin Elmer TotalChrom and recently implemented Thermo Fisher Chromeleon. Trackwise software for OOS, OOT and deviation investigation. iStability software for stability monitoring and trending. * Quality...

Tags for this Online Resume: Pharmaceutical, Pharmaceutical Industry, Quality Control Chemistry, Quality Control Chemistry, Quality Control, Accredited Pension Representative, Audit, QC Manager

Featured Profile

Quality Assurance and Compliance Professional- 15 Years of Experience - Near 91320

Quality Assurance/ Compliance Specialist in pharmaceutical or biotechnical industry where I can apply my background and skills to identify problem root causes and implement corrective actions. Support and participate in internal/external audits.

Ideal Companies: Johnson and Johnson, ECA Medical Instruments, Amgen, Thermo Fisher

Tags for this Online Resume: CAPA, Lean Green Belt, 5S, DMAIC, Root Cause Analysis, Audit, Continuous Improvement, Operations

Quality Management - 20yrs Experience

High-performing quality manager with 20+ years experience overseeing and implementing quality assurance operations/systems and managing performance in beverage manufacturing. Seeking a position to deploy my wealth of managerial experience to drive change that will add value to business growth, but also open to an entry level position as supervisor or project role in continuous improvement to prove my competences/skills.

Tags for this Online Resume: Quality/ISO Management, Microbial Analysis/Risk Management, COBRA/PMS, CAPA /Non Compliance control, Water/CSD/Juice Production, Training/Relationship Management

Medical Office Manager - 1 Years of Experience - Near 02120

Seeking a position to utilize my skills and abilities in the corporate sector that offers professional growth which is being resourceful, innovative and flexible. Knowledge of ICH guidelines and safety reporting requirements, good manufacturing practices (GMP), good laboratory practice (GLP) and good clinical practices (GCP). Understanding of FDA regulations and knowledge of IND, NDA, BLA, Drug Master File (DMF), 510(k) and...

Tags for this Online Resume: Boston, GLP, GCP, FDA Regulations, Medical Device

Principal Engineer

SUMMARY OF QUALIFICATIONS * Principal engineer, R&D and general management executive and scientific professional with B.S. M.S., Ph.D. and postdoctorate in science and engineering disciplines. * Successfully developed several prototypes and launched multiple FDA/CE regulated platforms, devices and Class I-II-III products and plastic consumables for medical, diagnostics, biotech and pharmaceutical applications from concept t...

Tags for this Online Resume: Orange County, CA, Medical Device, Research and Development, Principal Engineer, Manager and Director, FDA and CE regulated, Ph.D., Biotech

Clinical Quality Assurance - 17 Years of Experience - Near 27713

QUALIFICATIONS: QA / Quality Oversight, Data Integrity, Investigations, six sigma, CAPAs, TrackWise, Root Cause Analysis (RCA), Technical / Collaborative / Creative Writing, Microsoft Office, Inhalation, Stability, HPLC, Analytical Analysis, Quality Control (QC), Quality Assurance (QA), Audits, cGMP, cGLP, GxP, cGCP, method development/validation, Instrumentation/Automation, software, 21 CFR Part 11, FDA / ISO / Internation...

Tags for this Online Resume: Quality, Investigations, Regulatory, Writer, Raleigh, Data Review, Biotech, Test, Atlas, Automation, Data Entry, Documentation, Manufacturing, Protocol, Quality Assurance

Manager - 20 Years of Experience - Near 10901

I am seeking a middle to upper management position where I can apply my talent to the organization's Quality department. As my resume demonstrates, I'm highly adaptable to different industries, and making significant contributions at each opportunity. I am available for relocation for the right opportunity and compensation package.

Tags for this Online Resume: ISO Standards, CAPA, Root Cause Analysis, Management Rep., Lead Internal Auditor

Senior Quality Assurance Specialist

Summary of Qualifications Dedicated and solutions oriented professional with 14 years of medical device background mainly in Quality & Compliance * Highly motivated with demonstrated ability to set appropriate and effective priorities and implement decisions to achieve both immediate and long-term goals while managing multiple tasks and completing priorities. * Effective communication and inter-personal skills with all leve...

Tags for this Online Resume: Quality, Quality Assurance, Corporate Audit, Manufacturing, Raleigh RTP, Compliance, Internal audit, Supply Chain, FDA

Quality Engineer - 19 Years of Experience - Near 77459

SUMMARY Highly motivated, goal oriented, and efficient Quality Assurance professional with expertise in regulatory compliance, documentation, auditing, and process improvements. Known for ability to complete multi-faced tasks within strict time constraints. Demonstrated expertise in setting priorities and establishing appropriate detailed documentation to meet deadlines using strong clinical, analytical, and technical skill...

Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Audit, Complaints, ISO, ISO 9001, Management, Protocol, Manufacturing, ISO 13485

Department Manager - 6 Years of Experience - Near 33328

Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Manufacturing, Management, Product Development, Reliability, Asset Management, Engineering, FACETS, GMP, Projects, Maintenance, Devations, CAPAs, Design

Biomedical Engineer - 5 Years of Experience - looking for opportunities in NC or CO

I'm actively seeking more of a technical role in the medical device industry. Currently, I've served in sales, clinical, and service support roles for two large medical device companies. However, I'm trying to translate these skills and knowledge into either quality engineering, product development, R&D, or a field service role or similar. Also I am looking to relocate primarily to Colorado, North Carolina, or Oregon but I ...

Tags for this Online Resume: Complaints, Root Cause Analysis, Support, Surgery, biomedical, engineering, science, quality, product development, research and development, design, medical device, bioengineering, service, repairs, CAD, CAPA

Electromechanical Equipment Assembler - 1 Years of Experience

SUMMARY: * More than 5 years of Experience in cGMP regulated environment. * Manage control of changes, Deviations, OOSIR and CAPA * Review batch records and releases lots * Prepare and revise Standard Operating Procedure for cGMP Equipment * Work both independently and in team to finish project on-time. * Knowledge of FDA regulations and 21 CFR 210 & 211, cGMP/GLP/GDP guidelines for solid and liquid drug products.

Tags for this Online Resume: Manufacturing, Packaging, Documentation, Management, Quality, Quality Assurance, Quality Management, Test, Audit, Quality Control