What are the responsibilities and job description for the SPQA I position at FORMULATED Solutions LLC?
The Supplier Process Quality Assurance (SPQA) professional in the pharmaceutical industry ensures external suppliers (CMOs, vendors) comply with cGMP, regulatory standards, and internal quality agreements. Key duties include conducting supplier audits, managing quality agreements, investigating non-conformances, and approving changes to raw materials or manufacturing processes to ensure product safety and quality.
MAJOR DUTIES AND RESPONSIBILITIES:
- Learn and perform component inspections and Raw Material Sampling processes with direct oversight
- Learn proper use and application of measuring devices, such as but not limited to calibers, go-go gauges, pin gauges, scales and rulers
- Learn daily documentation adhering to Good Documentation Practices (GDP) for instrumentation (scales, gauges, etc.), Logbooks and Inspection Records
- Learn monitoring (temperature, cleaning) of cold and hot box storage areas.
- Learn to operate and complete certification for electric and manual pallet jack operation
- Learn and apply proper use and knowledge of PPE required
- Learn and understand how to read and follow SDS or other safety material provided.
- Learn and apply knowledge of basic cGMP’s, safety evacuations and reporting
- Learn and apply knowledge of reporting Safety and Quality events
- Learn and apply storage of raw material and component retains process
- Learn and apply accurate use of scanners
- Learn and apply understanding of warehouse locations and item identification
- Learn cGMP, safety and continuous improvement culture, to enhance customer satisfaction through accurate inspections.
- Participate in other activities as assigned by Quality management.
QUALIFICATIONS:
- Working knowledge of FDA regulations for drugs and/or medical devices.
- Knowledge of chemical safety and protective equipment.
- Must be able to lift up to 25 pounds on a regular basis.
CRITICAL SKILLS AND ABILITIES:
- Ability to use a personal computer and measuring devices.
- Attentive to detail, thorough and accurate
- Ability to lift, bend twist and stand continuously
- Ability to wear a full-face respirator
- Ability to establish priorities, work independently, productively, and proceed with objectives without supervision.
- Communicate with others clearly and concisely.
- Ability to work in a fast-paced environment – sometimes rapidly shifting priorities. Ability to concentrate in such an environment and perform quality work.
- Strong initiative, technical commitment and contribution to company and departmental goals.
- Strong understanding of cGMP, FDA/ICH guidelines, and risk assessment tools
- Strong technical writing, interpersonal skills for managing supplier relationships, and attention to detail.
EDUCATION AND/OR TRAINING:
- High School Diploma
- A minimum of one year experience working in an FDA regulated pharmaceutical or medical device environment or an equivalent combination of education and experience.