Description:
SCA Pharmaceuticals is a dynamic rapidly growing company consisting of passionate individuals who believe in our mission of providing high quality medications that are critical in saving and sustaining human life. SCA Pharma is an FDA 503B outsourcing facility providing customized medications for hospitals and healthcare facilities across the United States. We do this through unyielding quality, safety and integrity, our commitment to accountability and ownership, teamwork and creating better solutions by simplifying the complex.
Summary:
The Manufacturing Quality Assurance (MQA) Specialist - 2nd Shift is responsible for performing Root Cause Analysis (RCA) to determine the most likely cause of Quality Events (i.e., manufacturing deviations, environmental excursions. This role will require close collaboration with operations personnel of all levels.
Essential functions:
- Perform impact assessments, risk assessments and performs Root Cause Analysis for Quality Events.
- Implement appropriate Corrective and Preventative Actions (CAPAs) and monitor CAPA effectiveness with collaboration from Operational areas.
- Gather data from various sources across the site (ex. video review, trend data, and training records)
- Perform investigative interviews related to the Quality Events.
- Drive Quality Events to closure within on-time closure deadlines.
- Working cross-functionally with all departments to ensure Quality Events are thorough and accurate.
- Oversees all operational and pharmacy areas ensuring adherence to cGMP and Standard Operating Procedures
- Perform assessments during operations activities to ensure all work is performed in compliance with GMP, SOP and regulatory requirements
- Review cleanroom and supporting area documentation for accuracy and contemporaneous completion in batch records and logbooks
- Review executed batch records
- Proactively perform follow up on outstanding issues to ensure timely batch disposition
- Effectively disposition (release or reject) a batch ensuring compliance with regulatory and internal requirements
- Generate and approve SCA Certificate of Compliance
Requirements:
Required Qualifications & Experience:
- Bachelor's degree in life sciences, engineering, or related discipline.
- 3 years of quality experience in pharmaceutical, medical device or other related industries preferred
Desired Knowledge, Skills, and Abilities:
- Proficient in the Microsoft Office Suite (Excel, Word, Outlook)
- Ability to maintain gowning certification, enabling access to the cleanroom.
- Have effective communication (both written and verbal).
- Demonstrate strong technical writing skills, decision making abilities and critical thinking.
- Be able to manage multiple investigations and adhere to on time closure deadlines concurrently.
- Possess knowledge of aseptic technique.
SCA Pharma is an equal opportunity employer (Minorities/Females/Disabled/Veterans). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state, or local law.
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