Associate Specialist, Quality Control

Job Description

POSITION OVERVIEW – Basic Functions & Responsibility. Essential Functions Include, but Are Not Limited To:
Employee must show ability to perform routine assignments and develop competence by performing structured work assignments. Ability to use existing procedures to perform routine testing. Requires knowledge and exposure to fundamental laboratory instrumentation, theories, principles, and concepts. Receives instruction, guidance, and direction from others and also seeks advice/information from others when addressing serious business issues that may impact other functions.

Builds and promotes the team’s effectiveness through actions that demonstrate respect and appreciation for diverse perspectives. Demonstrates understanding of customer needs, requirements, and expectations. Seeks new ways to improve services to customers. Speaks up on tough issues and expresses views and ideas at the right time while actively encouraging team members to make suggestions and share ideas.

Works to develop new skills and abilities. Readily accepts performance feedback and incorporates this feedback into future performance. Assists other team members, including helping with developmental activities. Learns to use new problem‑solving tools to surface and solve issues. Applies general knowledge of company business developed through education and past experience. Ability to interpret the company’s Quality Policies, Guidelines, and Testing Procedures for daily application.

Understands and applies regulatory/compliance requirements, including GMP, NDA, and related regulations, and has the ability to interpret those regulations for implementation in the workplace. Possesses a basic knowledge of theories, practices, and procedures in the Quality Control discipline, including the knowledge and understanding of pharmaceutical testing. Active with developing technical writing capabilities and is able to compile straightforward investigations and procedures and recommend scientifically sound corrective actions.

Possesses a basic knowledge and ability to operate lab instrumentation required to complete job responsibilities. Uses existing procedures to perform routine testing. Ability to independently respond to basic requests for data and trending of data.

Communicates information and asks questions to check for understanding. Develops small‑scale presentations and presents to own work team or small groups with the assistance of others. Has limited decision‑making authority and works within technical guidelines/direction to achieve objectives and meet deadlines. Accountable for technical contribution to work or project team. Requires moderate to little supervision.

• Supports continuous improvement and supports sustainability of implemented changes. Identifies and implements continuous improvement changes within the laboratory.
• Ensures work is completed right the first time. Participates in root cause and corrective action identification and documents investigations.
• Participates and leads, when required, Tier I and Tier II activities.
• Demonstrates working knowledge of product performance and testing methodology.
• Provides an environment conducive with the 12 Inclusive Behaviors, actively promotes an inclusive culture and leads by example.
• Responds to and remediates audit observations.
• Demonstrates working knowledge of equipment and ensures proper usage of equipment occurs.
• Participates in coordination of testing activities within work team.
• Tests and interprets results for any of the following: raw materials, active pharmaceutical ingredients, water, microbial limit testing, and finished pharmaceutical products.
• Maintains compliance by following corporate policies/guidelines and local SOP’s.
• Interprets compendia and internal monographs, NDAs, and the company’s Quality Standards.
• Provides analytical support for cleaning validations, laboratory support requests, equipment validations, method transfers, and API Stability Packaging Description (ASPD).
• Assures laboratory compliance by adhering to cGMP, CFR, and other agency regulations.
• Revises laboratory procedures as required.
• Demonstrates leadership by…