Quality Assurance Specialist II, Material Management

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 

In this position, you will report directly to the Director of Quality Assurance and perform functions related to quality oversight of GMP material receipt, inspection, storage, inventory, release, and distribution of materials and finished products. You will work with the warehousing team to ensure that inventory control is maintained per established procedures and provide guidance and training related to these activities when needed. Your energy and excellent organizational skills will make you a key component in the successful management of materials in support of GMP manufacturing and distribution 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.

position Responsibilities

• QA oversight/support of activities related to the receipt, inspection, segregation, labeling, disposition and kitting of GMP materials.
• Verify cycle counts and perform inventory audits as required.
• Ensure compliance with safe handling and storage requirements, cGMP/ISO, site and corporate policies, and environmental/other related regulations.
• Ensure that material related deviations, CAPAs, and Change Controls are initiated and completed by warehousing personnel where required.
• Communicate with vendors any discrepancies/non-conformances related to materials as well as initiating Supplier Corrective Action Requests (SCARs).
• Author/revise SOPs related to the job function as needed.
• Support internal and external audits.
• Follow instructions and ensure compliance with applicable departmental SOPs.
• Provide training to warehouse personnel.
• Perform other duties as assigned.
• Lift up to 40 pounds unassisted and up to 60 pounds with assistance.
• 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 be able to effectively prepare communications to management with clarity and a high level of accuracy.
• Self-motivation and organizational skills to manage a workload independently, offering appropriate communication and escalation so solutions and support can be easily identified.
• Confident in making decisions for minor issues.
• Contributes to goals within the work group.
• Perform other related assignments and duties as required and assigned.

Education & Experience

• Bachelor’s degree with 2 - 3 years of experience, or a minimum of 5 years’ experience without degree in a GMP regulated Pharma/Biopharmaceutical environment. This experience must include activities related to GMP material management and packaging/shipping activities.
• Strong attention to detail and excellent organization skills.
• Knowledge of Good Manufacturing Practices (GMP).
• Knowledge of Good Documentation practices (GDP).
• Experience with material related deviations/investigations/CAPAs preferred.
• GxP knowledge of current FDA regulations requirements.
• 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.
• Proficient in Outlook, MS Word, Excel, PowerPoint and other applications.

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 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 40 pounds unassisted. 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.