Manages QA in-process personnel and functional processes.
Responsible for the training curriculum, supervising, developing, and supporting subordinate staff (QA Associates) that are responsible for reviews of quality system records.
Responsible for reporting issues related to cleanliness/repair/maintenance to Operations or Facilities Management and overseeing quality approval before continued use of the affected area or item.
Reviews, performs sampling, and disposition of product at various stages for: raw materials, in-process material and finished goods.
Ensures that periodic cleaning validations and production equipment validations/re-assessments are performed and documented within the timeframes specified.
Responsible for retain sample management.
Provides QA oversight and support for warehouse operations.
Assists with the collection of stability samples or special request samples for each lot.
Reviews Manufacturing, Packaging and Quality Operation processes and GMP documentation:
Executes reviews of batch records and release of finished products for sale
Conducts investigations/deviations/CAPAs of issues related to products
Reviews or prepares Master Batch Records, Master Packaging Records (where applicable), Finished Product Specifications, QC Testing Specifications for approval by QA Management
Prepares Change Controls and executes Validation Protocol Activities
Master Labeling, Finished Product C of A's, and SOP reviews
Provides periodic key performance reports to Senior Management as required
A back up person to QA Manager or Director of QA for conducting internal and 3rd party external compliance audits
Verifies and approves QC test results.
Leads and prepares documentation of investigation activities, performs root cause analyses, and develops CAPA plans for approval by QA Management
Additional Skills & Qualifications:
• At least three years pharmaceutical QA/QC environment.
• Must have experience of pharmaceutical in-process stages.
• Must have a good interpersonal and communication skill in English, understand both oral and written instructions, and be detail-oriented.
• Must possess the ability to handle multiple projects with competing deadlines.
• General computer knowledge of basic software, i.e. Microsoft Word, Excel, e-mail communication.
• Able to stand, bend and stoop for extended periods of time and ability to lift 45 lbs. unassisted.
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.