Quality Assurance Associate

THE COMPANY 

Scorpius BioManufacturing is an innovation-driven contract research, development and biomanufacturing organization offering clients a customized, integrated, end-to-end solution for their large molecule discovery research, process and analytical method development, cGMP manufacturing, product characterization, release testing needs, and clinical trial support. Our approach enables us to forge collaborative client relationships that move beyond the traditional service outsourcing model into full product development collaborations. 

POSITION SUMMARY 

Reporting directly to the Quality Assurance Manager, the Quality Assurance Associate will work with the Quality Assurance team to implement quality programs at Scorpius BioManufacturing. The Quality Assurance Associate will primarily be responsible for contributing to the company’s quality systems and compliance program and assist the Quality Assurance Manager in any activity pertaining to regulatory submissions.

The ideal candidate must be organized, self-motivated, and thrive in a fast-paced and dynamic biotech environment. She/he must be versatile and adapt to rapid change with a strong desire to make a significant impact. 

KEY RESPONSIBILITIES 

• Assist in the documentation/data for regulatory with a primary focus on non-clinical or clinical submissions to include, but not limited to, INDs, BLAs, 510Ks, etc.
• Responsible for QA systems and process coordination and management; including tracking and trending activities. Specific focus to be on process maintenance and improvement of existing quality systems and implementation and maintenance of new systems. 
• Responsible for the systems involved in the handling, processing, and distribution of all controlled documents in a federally regulated environment. This includes, but is not limited to, creation, indexing, tracking, and storage. 
• Responsible for maintenance of historical files of all products and archival records; including but not limited to change control, validations, process validations, method qualifications, batch records, clinical studies, etc. 
• Ability to apply a good working knowledge of cGMP, GLP and other regulatory requirements and agencies as it relates to quality systems and related activities. 
• Management of training documentation; including maintaining training database, filling training documentation. 
• Assist in Tracking and maintaining QA database, Deviation database, CAPA database.
• Assist in Tracking status/investigation/closure of corrective and preventive actions including complaint investigations.
• Assists QA auditors for audit preparation/closure as necessary (internal and external).
• Manages QA folders for audit reports, certificates etc. 
• Coordinate all scheduling activities for support of operations and process manufacturing and testing. Includes working with all departments to create, maintain, and attain schedules. 
• Track external vendor qualification. This includes coordination with Operations management to insure purchased raw materials and service(s) providers are qualified, including tracking activities for raw materials and services. 
• Review and approval of laboratory instrument and equipment qualifications and validations.
• Review and approval of change controls (pre and post) as they apply to laboratory/manufacturing processes, instruments, and equipment.
• Preparation of monthly/quarterly metrics on the quality system and identification of additional areas to track and measure. 
• Developing and implementing effective statistical techniques. 
• Responsible for assisting in all activities involving Quality Assurance including, but not limited to, staging, line inspections, support of manufacturing, and testing services. 
• Performs other work-related duties as assigned and directed by the supervisor.

EDUCATION & EXPERIENCE 

• B.S. in relevant field, 2 years of related experience and/or training; or equivalent combination of education and experience.
• 2+ years in commercial pharmaceutical or manufacturing with 1+ years of commercial regulatory affairs experience preferred.

KNOWLEDGE & SKILLS 

• Proficient with all Microsoft Office applications. 
• Be a self-motivated, customer-oriented person with excellent communication skills. 
• Work professionally with colleagues and be a team player; maintain flexibility with work projects. 
• Complete work in a timely, accurate and thorough manner.
• Think and work both tactically and strategically to provide operational needs to Scorpius' business.
• Ability to read, write and analyze complex documents. 
• Respond effectively to sensitive inquiries, customer inquiries or complaints as well as communicate effectively both orally and in writing with management, colleagues, and outside constituents. 

PHYSICAL REQUIREMENTS and working environment

• Flexibility is required for working hours. Some weekend work may be needed and earlier or later start/finish times may also be required.
• The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and laboratory environments and automated equipment. 
• While performing the job duties, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, and ability to adjust focus. The employee must have the manual dexterity and manual ability to effectively use computer terminals.