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Cheryl Paprota

Associate Director, Quality Assurance @ LTS - Lohmann Therapy Systems

Director of Quality Assurance at LTS - Lohmann Therapy Systems

Greater New York City Area

Ranked #518 out of 10,351 for Associate Director, Quality Assurance in New York

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Cheryl Paprota's Email Addresses & Phone Numbers

Cheryl Paprota's Work Experience

LTS - Lohmann Therapy Systems

Associate Director, Quality Assurance

November 2013 to Present

Merck (formerly Schering-Plough)

Associate Director Quality Operations, Stability Services and Quality Engineering

February 2010 to November 2013

Schering Plough

Manager, Customer Complaints

July 2008 to February 2010

Cheryl Paprota's Education

Lycoming College

Cheryl Paprota's Professional Skills Radar Chart

Based on our findings, Cheryl Paprota is ...

Realistic
Motivated
Measured

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Based on our findings, Cheryl Paprota is ...

52% Left Brained
48% Right Brained

Cheryl Paprota's Estimated Salary Range

About Cheryl Paprota's Current Company

LTS - Lohmann Therapy Systems

Frequently Asked Questions about Cheryl Paprota

What company does Cheryl Paprota work for?

Cheryl Paprota works for LTS - Lohmann Therapy Systems


What is Cheryl Paprota's role at LTS - Lohmann Therapy Systems?

Cheryl Paprota is Associate Director, Quality Assurance


What is Cheryl Paprota's personal email address?

Cheryl Paprota's personal email address is ch****[email protected]


What is Cheryl Paprota's business email address?

Cheryl Paprota's business email address is c****[email protected]


What is Cheryl Paprota's Phone Number?

Cheryl Paprota's phone (212) ***-*640


Who are Cheryl Paprota's colleagues?

Cheryl Paprota's colleagues are Lucja Orzechowski, Jörg Mayer, Michael Michael Heberle, Stefan Arnold, Nam G., Steven Grossman, Nitsa Mikell, and Anthony Piacentini


About Cheryl Paprota

📖 Summary

Accomplished, compliance minded individual with a comprehensive understanding of Quality Systems, cGMPs, CFR, and FDA Guidance documents. Successfully lead operational improvements focusing on continuous improvement and business driven initiatives. Experienced in developing and implementing compliance processes and related quality functions to support outsourced activities. An influential leader and site change agent possessing the ability to adapt to varying environments, with proven success in forging strong collaborative relationships with internal and external business partners.Associate Director, Quality Assurance @ From November 2013 to Present (2 years 2 months) Associate Director Quality Operations, Stability Services and Quality Engineering @ • Management of the Post Marketing Stability Surveillance Program: responsible for ensuring compliance with individual Regulatory filings, compendia requirements, cGMPs, and FDA Guidance Documents • Management of a cGMP compliant Reserve Sample Program • Managing the site’s Annual Product Review (APR) process, including the collection of data, analysis of the data, and reporting on the quality status of each product • Responsible for managing quality process management programs, such as Sampling Plans, Action/Alert Limits for the manufacturing and packaging activities, Yield Limits, Stability Release Limits, Assessment Capability Limits, Stability Typical Ranges, Process Capability Analysis, verification and extension of shelf-life, and investigation support • Supervising daily activities of a professional staff, providing for employee development, and conducting performance reviews • Monitoring department goals, budgets, metrics, and key performance indicators; and the identification of and/or implementation of initiatives to meet business objectives From February 2010 to November 2013 (3 years 10 months) Manager, Customer Complaints @ • Management of the Customer Complaint handling process for the site • Conducted comprehensive technical investigation of complaints • Trended complaints received and confirmed defects • Through the review of complaint trends or confirmed defects, identified areas for continuous improvement to reduce product quality complaints • Supervised daily activities of a professional staff, provided for employee development, and conducted performance reviews • Monitored department goals, budgets, metrics, and key performance indicators; and identified and/or implemented initiatives to meet business objectives. From July 2008 to February 2010 (1 year 8 months) Manager, Quality Services @ • Management of the Post Marketing Stability Surveillance Program: responsible for the program, as well as performed all related routine tasks, which included protocol development, coordination of the stability studies and testing at contract facilities and affiliates, data review, final reporting, and out of trend and out of specification investigations • Responsible for testing activities at contract facilities and ensured that sites remained in compliance with regulatory applications • Responsible for Annual Product Reviews and supervised the staff compiling the reports • Implemented processes and related quality functions to support outsourced activities • Composed technical documentation for Regulatory filings From September 2004 to July 2008 (3 years 11 months) Manager; Technical Services @ • Management of the Laboratory Equipment Qualification and the Laboratory Instrument Maintenance and Calibration Programs • Managed the Analytical Test Method Validation Policy • Developed method transfer protocols and supervised the successful transfer of analytical methods to third party contractors or within the site • Member of the company wide CAPA Board: provided technical guidance for root cause analysis and reviewed and provided comments on all site investigations and CAPAs • USP Pharmacopeial Forum (PF) Review: reviewed the PF and supplements for proposed changes to methods and monographs that impacted current products and laboratory procedures. Developed and coordinated studies to evaluate changes, initiated change controls, and implemented changes From December 2001 to September 2004 (2 years 10 months) Team Leader, Analytical Method Development Lab @ • Supervised a team of scientists in the laboratory and represented the department on a global level for analytical development projects • Supervised development and validation of analytical methods, method transfers, and routine analysis in support of product stability and release • Prepared SOPs, protocols, reports, and out of specification and out of trend investigations From March 1997 to October 2001 (4 years 8 months) Pharmaceutical Development Pharmaceutical Scientist I, II @ • Developed and validated HPLC analytical methods in support of release, stability, and cleaning validations • Performed routine stability analysis via HPLC, GC, UV, Dissolution, UV-Vis, IR, and other instrumental methods to support formulation development and regulatory submissions • Responsible for the laboratory Reference Standard Program • Analysis of stability samples to support regulatory submissions • Analysis of raw materials • Performed identification testing in support of clinical studies From 1988 to 1997 (9 years) Cheryl Paprota is skilled in: GMP, SOP, Validation, FDA, CAPA, Pharmaceutical Industry, Quality System, 21 CFR Part 11, Change Control, Quality Control


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In a nutshell

Cheryl Paprota's Personality Type

Introversion (I), Sensing (S), Thinking (T), Perceiving (P)

Average Tenure

4 year(s), 0 month(s)

Cheryl Paprota's Willingness to Change Jobs

Unlikely

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