Quality Assurance Specialist (3:00pm-11:30pm)
SUMMARY: The Quality Assurance Specialist I is responsible for performing Manufacturing Quality Assurance (MQA) oversight of GMP compounding and support activities at SCA Pharmaceuticals. The Quality Assurance Specialist I assists system owners in performance of non-conformance investigations, executes CAPA's as they pertain to the QA department and supports validation and technical change control activities. This position requires advanced understanding of site processes in order to write technical documents including engineering studies and standard operating procedures.
The position is a non-management position. The individual occupying it is expected to be capable of working with minimal supervision. The Quality Assurance Specialist I is expected to communicate well with fellow Quality Assurance employees as well as Operations and Quality Control departments.
ESSENTIAL FUNCTIONS:
SUCCESSFUL CANDIDATES WILL HAVE:
Detail oriented and strong organization skills with 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 work independently with minimal supervision and also collaboratively with cross functional teams
Proficiency in the use of a personal computer with expertise in Microsoft Word, Excel, and PowerPoint
Candidates must be able to accommodate shift schedule. Shifts may include routine weekend and evening work as required by the manufacturing process
Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice
SUPERVISORY RESPONSIBILITIES
WORK ENVIRONMENT
PHYSICAL DEMANDS
QUALIFICATIONS:
Knowledge: Familiarity with regulatory requirements for a 503B Compounding Outsourcing Facility, or applicable experience in sterile pharmaceutical, medical device, or biotech manufacturing and a thorough knowledge and understanding of cGMP preferred
Skills: Leadership, critical thinking, decision-making, effective communication
SCA Pharmaceuticals 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.