Quality Assurance (QA) Specialist

Description

Company 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 sustain 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) Specialist assists system owners in performance of investigations and approves Event Investigations and Laboratory Event Investigations as well as, approves closure of CAPAs and Change Controls. The Quality Assurance Specialist approves Master Batch Records and label, product, and raw material specifications. This position assists in performing Internal Audits at the site as well as provides GMP training to the site.

Essential Functions:

• Perform Internal Audits of operational areas for cGMP compliance and adherence to Standard Operating Procedures (SOPs), including follow-up with owners for responses to findings.
• Review and approve Quality Event (QE) investigations (Deviations, Micro Excursions, Out-of-Trends, Events, Continuous Monitoring System excursions, CAPAs) as well as assisting owners during investigation if needed.
• Provide guidance, as requested, to production employees with the intent to foster understanding and compliance with SOPs, GMPs and process improvements
• Provide input and decision making for quality on the shop floor regarding manufacturing deviations and provide corrective actions as necessary
• Author, review and/or approve technical documents for the site including standard operating procedures, visual displays, technical qualifications, investigations, technical change controls, and corrective and preventative action plans and effectiveness checks
• Review and approve specifications for labels and finished products
• Review process variability reports, stability protocols, and stability reports
• Review and approve master batch records
• Perform data analysis, identify corrective/preventative actions, process deviations and investigation reports
• Perform inspection and release of incoming raw materials
• Assist with customer and supplier complaint investigations as part of QA investigations
• Assist with supplier qualification functions such as supplier audits and supplier quality agreements
• Assist in the coaching and training of employees for required Quality Assurance related initial and annual cGMP and GDP training
• Track, trend, analyze, and report on Quality and Business indicating data
• Performs other duties as assigned
  
  
  

Requirements

Required Qualifications & Experience:

• Bachelor’s degree in life sciences, engineering, or related discipline.
• 2 years of quality experience in pharmaceutical, medical device or other related industries preferred
• Familiarity with regulatory requirements for a 503B Compounding Outsourcing Facility, or applicable experience in sterile pharmaceutical, medical device, or biotech manufacturing
• Thorough knowledge and understanding of cGMP preferred
  
  
  

Desired Knowledge, Skills, and Abilities:

• Proficient in MS Word, Excel, and PowerPoint
• Detail oriented, strong organization skills, and the ability to provide strategic and improvement recommendations/solutions
• Ability to multitask efficiently and identify roadblocks prior to project milestones
• Strong communication skills driving organizational engagement
• Ability to be flexible in a fast-paced environment
• Ability to travel to perform off-site supplier audits
• Ability to work independently with minimal supervision and collaboratively with cross functional teams
• Ability to sit, stand and walk often throughout all areas of the site
  
  
  

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.