Description
The Quality Assurance Specialist will serve as the key interface with corporate personnel and third party partners for day to day support of drug substance and drug product manufacturing, including third party management, internal/external auditing, exceptions management (PTC, Deviations, CAPAs), change control, batch review, and validation documentation review.Responsibilities:
- Assist with the management of controlled QA documents (production batch records, change controls, deviations, CAPAs, procedures, validation protocols, raw material and intermediate material specifications, training documentation, etc.) and associated systems in compliance with applicable regulation (e.g. 21 CFR Parts 11, 210 and 211).
- Conducting final product batch review, including QC documentation review from third parties.
- Performing method, process, equipment, and cleaning qualification/ validation documentation review/approval for drug substance/drug product.
- Supporting and participating in routine audits of internal departments/functions and third parties (CMOs and Labs) to ensure quality systems practices are consistent across all SYN and third party sites.
- Assist with Administration of corporate training program.
- Assist with creation/revision and implementation/administration of quality systems.
- Tracking Quality System metrics and periodic review data.
- Assist with Annual Product Review for applicable products.
- Proposing quality improvements to Quality Systems to maintain compliance and improve efficiency utilizing risk-based methodologies.
- Assisting with corporate and third party inspection readiness activities.
- Providing support and contributing to other Quality Assurance activities as necessary.
Qualifications:
- A Bachelor's Degree in Chemistry, Biology, or Life sciences, or equivalent education or experience is required.
- 3+ years' experience with Quality Systems in the drug, biopharmaceutical or medical device fields.
- Experience in implementation and maintenance of quality systems.
- Demonstrated knowledge of Quality Systems and cGMP within an FDA-regulated environment.
- Must be well organized and able to grasp system concepts and communicate their applications.
- Excellent oral and written communication skills for effectively interfacing with internal and external organizations.
- Ability to handle multiple assignments in a fast-paced environment with changing priorities.
- Competency in MS Office, Adobe Acrobat, and quality systems databases.
- Ability to travel up to 25% of the time (domestic and international).
- Excellent communication skills, in both verbal and written form.
- Ability to influence and work independently and in a team environment.
- Negotiation and conflict management skills.
To find out more about Real please visit www.realstaffing.com