Quality Assurance Specialist I

Kindeva Drug Delivery•Lexington, KY

12d•Onsite

About The Position

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make: As a Quality Assurance (QA) Specialist I, you will provide critical oversight and support of pharmaceutical manufacturing operations 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. 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.

Requirements

Bachelor degree in a scientific discipline (preferred experience may be substituted for education)
At least 0-3 years Pharmaceutical/Medical Device cGMP quality experience
Knowledge of data integrity principles (ALCOA+) and compliance with 21 CFR Part 11 for electronic records
Knowledge of HPLC principles and ability to review data for accuracy and completeness
Knowledge of microbiological testing principles and ability to review data for accuracy and completeness
Ability to assess problems, to identify solutions, to plan and implement necessary changes
Ability to work well in a team-oriented environment
Well-developed communication and technical writing skills
Qualified to work with controlled substances
Experienced in leading and assisting in deviation investigations and implementation of appropriate CAPAs.

Nice To Haves

Experience in quality systems auditing (internal and/or external) preferred
Familiarity with electronic QMS platforms (e.g., TrackWise, MasterControl,etc).
Experience in manufacturing aseptically filled, sterile products preferred
Advanced knowledge of cGMP regulations and validation principles (e.g. FDA 21 CFR Part 820, ISO 13485, etc)

Responsibilities

Supports on-shift manufacturing operations and activities including but not limited to real time auditing of production batch records, sampling and AQL, line clearances.
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 deviation, OOS, CAPA and Change Control Systems:
Evaluate proposed changes to processes, equipment, materials, or documentation to ensure compliance with regulatory and quality standards.
Participate in investigations and root cause analyses for deviations, OOS results, and audit findings.
Ensure timely implementation and effectiveness checks of CAPAs to prevent recurrence of quality issues.
Reviews, and approves cGMP documentation including but not limited to procedures, batch records, validation protocols, development reports, specifications, raw data, executed batch records, material and batch disposition, 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 on-going 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 Manager with daily and project activities as needed.
Other duties as assigned.