Job Overview:
The QA Associate ensures compliance with cGMP and internal policies, procedures, and specifications. This position is responsible for performing a role in any one or more of the following functions: Quality Operations, Process Quality, Batch Release, Quality Systems, and Compliance in accordance with cGMP and related company SOPs, state, federal and local laws as applicable.
Responsibilities:
- To complete quality assurance tasks as directed by the supervisor associated with the review of operations performed within the site. These may include product release, process quality, quality systems & operations, and compliance.
- To support or contribute to the preparation, review, and approval of QA-related documentation in accordance with approved SOPs.
- To perform or assist in general organizational tasks including oversight and escalation of open tasks and timelines, tracking of tasks, generation of technical reports, and reporting of quality metrics.
- To ensure that appropriate quality standards are applied in accordance with regulatory, pharmacopeias, and company requirements.
- To assist in quality-related activities that may include the preparation and review of GMP documentation.
- To escalate compliance issues appropriately when discovered.
- To complete assigned training in a timely fashion to ensure that both personal and department training status remains current.
- Review data to ensure conformance to product specifications and maintain quality assurance objectives to meet regulatory requirements.
- Respond to external customers.
- Perform other duties as assigned.
Qualifications:
- Bachelor's degree, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
- Minimum of 3+ years of Quality Assurance experience in a GMP-regulated industry, such as pharmaceutical, biologics, medical devices, or in combination with relevant education
- Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.
- Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
- Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
- Must be able to comprehend and follow all applicable SOPs.
- Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
- Demonstrate understanding/ability to acquire the appropriate knowledge from resources on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
- Good understanding of cGMPs, industry, and regulatory standards and guidelines.
- Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
- Demonstrate the ability to portray the appropriate level of integrity and professionalism.
- Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
- Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
- Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
- Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Results-oriented and efficient.
- Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
- Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
- Demonstrate the ability to work well in a cross-functional team environment.
- Must communicate fluently in English and have legible handwriting.
Physical Demands:
- Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
- Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
- Ability to lift up to 40 pounds on occasion.
- Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).
25 To 35 (USD) Hourly
