Quality Assurance (QA) Manager
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Job Location:
Little Rock, AR - USA
Monthly Salary:
Not Disclosed
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
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 Quality Assurance (QA) Manager leads a cross-functional Quality Assurance team. The Quality Assurance (QA) Manager is responsible for ensuring GMP compliance and adherence to SOPs for all operations including but not limited to label/log generation material picking and sanitization sterile compounding cleaning/sanitization of the aseptic areas inspection labeling and packaging warehouse and shipping processes microbiological and chemical analytical testing.
Essential functions:
- Provides oversight of the key quality systems (ex. Deviation Change Control and CAPA) by tracking status and progress and reporting Key Quality Indicators (KQI) to site leadership.
- Responsible for the continuous improvement and implementation of the Incoming Quality Assurance (IQA) program Manufacturing Quality Assurance (MQA) program and Batch Record Release (BRR) program as applicable.
- Drives delivery of day-to-day Quality Assurance activities ensuring adherence to plan and schedule.
- Provides advice and knowledge regarding interpreting Good Manufacturing Practice guidelines and regulations.
- Responsible for ensuring the SCA SOPs Batch Records and Forms are compliant with cGMPs cGDPs and consistent with other SCA policies and procedures
- Reviews and approves investigations (including but not limited to deviations Out-of-Specification Environmental Monitoring Excursions) and provides advice and knowledge during investigation to ensure appropriate root cause and corrective actions are determined.
- Reviews and approves raw material and finished product specifications.
- Reviews and approves internal audits supplier complaints and customer complaints.
- Reviews and approves new and revised SOPs Change Controls and CAPAs.
- Schedules employees regarding workload and backlog to ensure efficiency.
- Proactively looks for opportunities to identify change increase efficiency influence decisions and deliver results while ensuring compliance.
- Responsible for hiring training and development of direct reports.
- Additional responsibilities as assigned
Required Qualifications & Experience:
- Bachelors degree in in life sciences engineering or related discipline.
- 5 years of quality experience in pharmaceutical medical device or other related industries.
- 3 years of supervisory experience
Desired Knowledge Skills and Abilities:
- Proficient with Microsoft Office Suite (Word Excel PowerPoint Outlook)
- Strong written and verbal communication skills.
- Proven ability to work cross-functionally to achieve business outcomes
- Familiarity with regulatory requirements for 503(b) sterile compound outsourcing facilities
- Leadership critical thinking decision making Demonstrates skill in maintaining internal customer relationships.
- Effectively lead and train employees.
- Strong attention to detail
- Goal oriented with excellent time management and organizational skills
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.
Required Experience:
Manager
Key Skills
- Quality Assurance
- FDA Regulations
- Food Industry
- Food Safety Experience
- ISO 9001
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- QA/QC
- Selenium
- HACCP
About Company
SCA Pharma is a customer and patient centric service provider in the 503B industry. Licensed in all 50 states, SCA Pharma offers a robust catalog, as well as outstanding quality and customer service.
