Spclst, Quality Control

Job Description

Our Quality Assurance Group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Summary, Focus and Purpose

•  The Quality Control Specialist requires knowledge and experience in the Quality Control discipline and solves a range of straightforward problems.

• Analyzes possible solutions using standard procedures.

• Builds knowledge of the company, processes, testing and customers.

• Receives a moderate level of guidance and direction and also proactively seeks advice/information from others when addressing serious business issues that may impact other functions.

• Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group while contributing and adding value to the achievement of team goals.

• Demonstrates a deep understanding of customer needs, requirements, and expectations.

• Continuously seeks new ways to improve services to customers and lean initiatives in the laboratory.

• Speaks up on tough issues and occasionally challenges the status quo. 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.

• Good organizational and time management skills.

• Assists in direction of plant wide or department objectives.

• Understands the fundamental business drivers for the company and uses this knowledge in own work and is proficient in multiple functional areas of the laboratory.

• Ability to interpret our Company Quality Policies and Guidelines 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 an expanded knowledge of theories, practices, and procedures in the Quality Laboratory, including the knowledge and understanding of pharmaceutical testing.

• Possesses strong technical writing capabilities and is able to compile more complex investigations, procedures, justifications, qualifications/validation protocols, etc.

• Possesses an advanced knowledge and ability to operate multiple instruments required to complete job responsibilities with the ability to generate data and reports from these instruments.

• Identifies and solves a range of problems in straightforward situations and analyzes possible solutions and assesses each using standard procedures.

• Ability to objectively respond to advanced requests for data and trending of data and proactively utilizes trending of data to improve the operation or drive change.

• Explains information and persuades others in straightforward situations.

• Develops presentations which includes those needed to influence the actions and decisions of others and presents to own work team or large groups with limited assistance of others.

• Makes decisions within guidelines and policies that impact own priorities and allocation of times to meet deadlines.

• Recommends scientifically sound corrective and preventive actions.

• Accountable for technical contribution to work or project team and may lead or manage a small project team.

Key Functions

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

• Completes a variety of testing to support release and stability requirements for a variety of products