Melissa Strohl

Melissa Strohl Email and Phone Number

Quality Assurance and Compliance Manager @ Particle Size Technology Inc
Sellersville, PA, US
Melissa Strohl's Location
Sellersville, Pennsylvania, United States, United States
Melissa Strohl's Contact Details

Melissa Strohl personal email

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Melissa Strohl phone numbers

About Melissa Strohl

I have 19 years of experience in pharmaceuticals in the areas of manufacturing and Quality Assurance. 2+ years of experience in OTC drug and cosmetic/personal care manufacturing and Quality/Regulatory. I am currently the Quality Assurance/Compliance Manager at Particle Size Technology, Inc in Quakertown, Pa.

Melissa Strohl's Current Company Details
Particle Size Technology Inc

Particle Size Technology Inc

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Quality Assurance and Compliance Manager
Sellersville, PA, US
Employees:
15
Melissa Strohl Work Experience Details
  • Particle Size Technology Inc
    Quality Assurance And Compliance Manager
    Particle Size Technology Inc
    Sellersville, Pa, Us
  • Particle Size Technology Inc
    Quality Assurance/Compliance Manager
    Particle Size Technology Inc Aug 2021 - Present
    Quakertown, Pennsylvania, United States
  • Fmi
    Regulatory Affairs Specialist
    Fmi Jan 2019 - Aug 2021
    Allentown, Pa
    My current job duties include:⦁ Collaboration with Production Operators, Department Supervisors and Department Managers throughout the company to generate new procedures and review /revise existing procedures.⦁ Approval of SOP’s and company documents which also includes issuing current revisions of SOP’s and company forms and maintaining control of these documents. ⦁ Managing training for all personnel on new and revised SOP’s and company forms and maintaining training files for each employee.⦁ Managing cGMP Training for new employees as well as annual cGMP training and periodic special topic training for all current employees including maintaining accurate and up-to-date documentation of all training conducted. ⦁ Managing the certification program for organic OTC products, managing FDA registration for OTC products and managing various other registrations and certifications for the company and it's customers.⦁ Working with vendors to obtain necessary Regulatory documentation for raw materials. ⦁ Providing documentation for customers regarding California Proposition 65, CITES, Allergen warnings, animal testing, certificates of origin and GMP compliance. ⦁ Supplying data for generation of SDS documents for finished product.⦁ Performing Label review for FDA compliance.⦁ Performing formulation review for restricted/prohibited ingredients.⦁ Review of raw materials and laboratory testing for claim substantiation.Additional experience includes hosting various audits from the FDA, CCOF and individual customers. I have also participated in interdepartmental process improvement teams (Safety Team, Annual Product Review Team).
  • G&W Pa Laboratories, Llc
    Senior Quality Assurance Auditor Ii
    G&W Pa Laboratories, Llc Apr 2015 - Jun 2017
    In April of 2015 G&W Laboratories acquired the Sellersville, Pa manufacturing plant from Teva Pharmaceuticals. I remained in my position as Quality Assurance Auditor at the Sellersville site and continue to perform the same job duties as my previous position with Teva.
  • Teva Pharmaceuticals
    Senior Quality Assurance Auditor Ii
    Teva Pharmaceuticals Oct 2007 - Apr 2015
    Sellersville, Pa
    I have 8+ years experience in Quality Assurance where job duties include performing potency calculations for the dispensing of API raw material, release of raw material for production use, release of commercial batches for packaging, review and final release of commercial batches for distribution, ensure compliance to cGMP, review and final release of contract packaged commercial batches, investigation and justification of both major and minor deviations in production departments as well as in the Quality Control and Microbiological Laboratories, and coordination and assignment of tasks related to the review/approval of Master Production and Packaging Batch Records. Additional duties include oversight of non-commercial NDA and ANDA batches, documentation review for non-commercial batches, review and release of laboratory testing for commercial and non-commercial batches and monitor, review and approval of change control documents, revision of existing SOP’s and generation of new SOP’s, and providing support for the entire plant.
  • Teva Pharmaceuticals
    Lead Pharmaceutical Operator - Liquids/Creams/Ointments
    Teva Pharmaceuticals Aug 2001 - Oct 2007
    Teva Pharmaceuticals, Sellersville, Pa
    I have 6 years of experience as a Lead Pharmaceutical Operator in the Liquids, Creams and Ointments department where job duties included dispensing of raw materials used to manufacture batches, manufacturing of all liquid and semisolid products including documentation of batch record steps and reconciliation of batches, final departmental review of batch records, initiation of Incident Reports when necessary, assisting Research & Development and Process Engineering in the manufacture of NDA and ANDA batches, routine maintenance and calibration of all manufacturing equipment. Additional responsibilities included creation and revision of departmental Standard Operating Procedures including all associated training, and monitoring completion of CAPA.
  • Teva Pharmaceuticals
    Line Leader, Packaging Department
    Teva Pharmaceuticals Sep 1998 - Aug 2001
    1-year experience as a Line Leader in the packaging department where job duties included but were not limited to the operation of packaging line equipment, performing in-process quality checks, generating IR’s, performing batch reconciliation and paperwork review, training of new employees and overseeing the general operation of the packaging lines.2 years experience as a machine operator in the packaging department where job duties included operation of the packaging line equipment, completion of batch documentation, performing net content count checks, and training of new employees.

Melissa Strohl Skills

Change Control Sop Gmp Lean Manufacturing Capa Pharmaceutical Industry Quality Assurance Fda Quality Auditing Software Documentation Quality Control Manufacturing Validation Incident Investigation Document Review Pharmaceutics 21 Cfr Part 11 Documentation Review

Melissa Strohl Education Details

Frequently Asked Questions about Melissa Strohl

What company does Melissa Strohl work for?

Melissa Strohl works for Particle Size Technology Inc

What is Melissa Strohl's role at the current company?

Melissa Strohl's current role is Quality Assurance and Compliance Manager.

What is Melissa Strohl's email address?

Melissa Strohl's email address is me****@****mfg.com

What is Melissa Strohl's direct phone number?

Melissa Strohl's direct phone number is +126721*****

What schools did Melissa Strohl attend?

Melissa Strohl attended Delaware Valley University, Northampton Community College.

What skills is Melissa Strohl known for?

Melissa Strohl has skills like Change Control, Sop, Gmp, Lean Manufacturing, Capa, Pharmaceutical Industry, Quality Assurance, Fda, Quality Auditing, Software Documentation, Quality Control, Manufacturing.

Who are Melissa Strohl's colleagues?

Melissa Strohl's colleagues are Scott Schatz, Trevor Chenette, Kevin Scorzafava, Megan Hamilton.

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