SUMMARY:
The Manufacturing (Operations) Quality Assurance (MQA) Specialist is responsible for ensuring correct implementation of all operations, including but not limited to label/log generation, material picking and sanitization, sterile compounding, cleaning/sanitization of the aseptic areas, sampling of finished product, inspection, labeling and packaging, warehouse and shipping processes; microbiological testing; and chemical analytical testing.
This position reports to the Quality Assurance Manager. This position will have the authority to assesses GMP areas, aseptic technique and the adherence to SOP of the compounding technicians and pharmacists during compounding activities. This position will also assess all production support areas to ensure adherence to SOP. In addition, this position will assist with questions, concerns, and non-conformances as they occur inside and outside the cleanroom. This position is also responsible for batch record review and final product disposition, overseeing and coordinating Clean Room fit/finish inspections, QA oversight during process simulation trials/media fills and overseeing and coordinating gowning qualifications.
The MQA Specialist is expected to be capable of working with minimal supervision as they oversee all areas of operations. This position is expected to communicate well with all levels of the organization.
THIS IS A 2ND SHIFT POSITION: 2PM - 11PM.
ESSENTIAL FUNCTIONS:
Production Support
Batch Record Review and Product disposition
Other Activities
Assist with management of the Gowning Qualification Program; maintain requalification schedule and oversee gowning applicating during qualification activities
Support Validation Department and provide QA oversight during Media Fills
Participate in and coordinate Clean Room fit/finish inspections
Support Facilities and Validation Departments during shut-down activities
Assist Operations Department with the investigation of deviations/non-conformances by providing guidance and support to in root cause determination and reviewing the impact and criticality of the event with respect to product function, quality, effectiveness, safety, reliability and customer satisfaction
Assist with the aseptic and GMP training for department's new hires and current employees, as required.
Evaluates SCA SOPs, Batch Records and checklists for compliance with cGMPs, cGDPs, and consistency with other SCA policies and procedures
Assisting in the development and the updating of SCA SOPs for compliance with cGMPs and consistency with other SCA policies and procedures
Represents SCA in a professional manner, at all times
SUCCESSFUL CANDIDATES WILL:
WORK ENVIRONMENT
PHYSICAL DEMANDS
QUALIFICATIONS:
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.