QA Specialist

2 months ago

Lexington, United States Kindeva Drug DeliverySummit Biosciences Full time

Kindeva Drug Delivery is a leading global contract developer and manufacturing organization (CDMO) with delivery platform experience and expertise in autoinjector, inhalation, transdermal/intradermal patch, and nasal spray technologies.
The Lexington location develops, manufactures, and commercializes prescription nasal spray products and is experiencing increasing continuous growth.
We partner with our customers to improve patient outcomes around the world.
Together, as One Team, we will manufacture more tomorrows. If you are ready to work for a purpose, join our team

 Position Responsibilities:

Responsible for providing quality involvement and oversight during all stages of pharmaceutical development, manufacturing, and testing.
Also responsible for review of controlled cGMP documentation and manufacturing records including any deviations or OOS that may have occurred during lot production and investigations.
Participates during the release of raw materials, intermediates, and final products.
Performs internal and external audits of facilities and products, observes critical operations and procedures as they occur, audits documentation, records activities and keeps management informed on quality issues.

 Essential Duties:

  • Supports the development and maintenance of Quality Systems as appropriate.
  • Leads continuous improvement objectives to assure compliance with DEA and FDA regulations.
  • Advises senior management on findings and recommendations related to internal and external auditing.
  • Manages the CAPA and Change Control Systems.
  • Reviews, and approves cGMP documentation including procedures, batch records, validation protocols, development reports, specifications, and other related documents.
  • Develops and maintains metrics and trending reports for Compliance-related activities.
  • Reviews and approves product complaint investigations and assists with investigations.
  • Performs activities associated with various one-time or ongoing projects (from participation level to project manager).
  • Collaborates with departments and external suppliers regarding quality concerns.
  • Participates and/or coordinates Compliance Assessments of departments as necessary (GXP, Part 11, etc.).
  • Supports regulatory inspections and customer audits.
  • Assists the Manager with daily and project activities as needed.
  • Other duties as assigned.

 Qualifications: 

  • Bachelor's degree in a scientific discipline
  • At least 7 years of Pharmaceutical/Medical Device cGMP quality experience
  • Knowledge of HPLC principles and ability to review data for accuracy and completeness
  • Ability to assess problems, to identify solutions, to plan and implement necessary changes
  • Experience in quality systems auditing (internal and/or external) preferred
  • Experience in manufacturing aseptically filled, sterile products preferred
  • Advanced knowledge of cGMP regulations and validation principles
  • Ability to work well in a team-oriented environment
  • Well-developed communication and technical writing skills
  • Qualified to work with controlled substances
 Equal Opportunity Employer:
 Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law

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