Quality Assurance Specialist III, Operations

The Company

Scorpius BioManufacturing is a boutique biologics CDMO providing cGMP manufacturing, bioanalytical, and process development services for protein modalities. Our facility in San Antonio, Texas specializes in working with start-ups, emerging biotechs, and academic researchers.  Scorpius was founded by a serial biotech entrepreneur determined to make small-volume programs a big priority. Clients benefit from decades of expertise taking large molecule drugs to market and can rely on Scorpius to offer Quality, Speed, Flexibility, & Responsiveness.

Position Summary 

This role will be responsible for the support of GMP compliance with a focus on Manufacturing. The candidate will provide critical review, organization, and Quality oversight of records generated during GMP manufacturing, release, and stability testing of Drug Substances/Drug Products, as well as analytical records. They will make sure that product and manufacturing process records are within the specifications established and include complete information relating to the production and control of each manufacturing lot at Scorpius BioManufacturing.

The ideal candidate must exhibit attention to detail and good time-management skills to adapt with rapid business goals; and be organized, self-motivated, and thrive in a fast-paced and dynamic biotech environment. She/he/they must be versatile and adapt to rapid change with a strong desire to make a significant impact.

DUTIES & Responsibilities

• Provide ongoing support to manufacturing operations, review and approve product-related documentation, including batch records, quality control test results, and certificates of analysis, etc.
• Monitors production conformance with QA standards and procedures.
• Act as the QA representative on the floor during manufacturing operations and audit operations as needed.
• Perform cleanroom release activities.
• Responsible for labeling controls and verification of critical product labeling information such as lot number, expiration date, product description, and manufacturing date.
• Participate in the initiation, documentation, and management of quality events (e.g., deviations, CAPAs, change control, SCARs)
• Contribute to deviation/Non-conformance management procedure improvement.
• Ensure Change Controls are initiated, evaluated, and implemented appropriately for all regulated changes.
• Review and approve change control records.
• Contribute to the maintenance and reporting of metrics related to batch record review and product disposition in support of the Management Review.
• Assist with implementation and maintenance of the GMP training system.
• Author, review, and approve standard operating procedures (SOPs), quality policy documents, and laboratory/batch records.
• Train Quality Specialists and/or Operations teams on quality topics where applicable.
• Develop and/or maintain Quality System metrics for Management Review
• Support GMP material receipt, inspection, and release activities as needed.
• Review of material qualification packets.
• Support inspection readiness plans and interact with regulatory agencies during inspections as needed.
• Assist with performing internal and/or external audits and inspection readiness activities, as needed.
• Must be skilled in planning, organizing, decision-making, and building relationships.
• Maintain the standards of ethical behavior and conduct to promote a quality culture within the organization.
• Perform other related assignments and duties as required and assigned.

required competencies

• Able to effectively work in a dynamic/fast-paced environment Must work collaboratively with multiple departments for efficient and timely completion of assigned tasks.
• Must have strong authorship and be able to critically review executed documents and protocols.
• Must be able to effectively prepare communications to management with clarity and a high level of accuracy.
• Must be action-oriented and customer-focused, building relationships, problem-solving, planning and organizing, conflict management, coaching others, and analytical thinking.
• Must possess an independent mindset and tenacity.
• Requires moderate direction to complete complex tasks; completes routine tasks with little or no supervision. Work is self-directed.
• Confident in making decisions for minor issues.
• Contributes to goals within the workgroup.
• Knowledge of aseptic manufacturing processes.
• Excellent verbal and written communication skills
• Technical understanding of biopharmaceutical production, with experience in cell and gene therapy a plus.
• Self-motivation and organizational skills to manage a workload independently, offering appropriate communication and escalation so solutions and support can be easily identified.

Knowledge & Skills 

• GxP knowledge of current FDA, EMA, and ICH regulations requirements.
• Proficient with all Microsoft Office applications.
• Ability to work independently and as part of a team to complete assignments by deadlines and time schedules.
• Good verbal and written communication skills to interact with different departments, skill levels, and external personnel.
• 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.

Education & Experience

• Bachelor of Science in Physical Sciences, Engineering, related discipline, or equivalent is required.
• 4 to 5 years’ experience in related cGMP environment;       Biologics, Cell Therapy, Pharmaceutical.
• Experience with conducting Root Cause Analysis Investigations and CAPA management preferred.
• Experience with GMP material management and packaging/shipping activities preferred.
• Experience with internal and external audits preferred.
• Experience reviewing and interpreting executed IOPQ’s (Equipment/CSV) preferred.

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, color vision, and ability to adjust focus. The employee must have the manual dexterity and manual ability to effectively use computer terminals.