Associate Specialist Quality Control

Job Description Position Overview

• Maintains final retention of all manufacturing and packaging documentation and samples.
• Coordinates and prepares documentation for shipment of raw material and finished goods retention sample shipment to and from Wilson and other plant sites.
• Receives production samples for use in retention program, and enters sample information into Trackwise system
• Completes annual inspections of retained samples
• Tracks sample levels
• Coordinates the archival and retrieval of batch record documentation

• Ability to perform routine assignments and develops competence by performing structured work assignments.
• Ability to use existing procedures to solve routine and standard problems.
• Requires knowledge and exposure to fundamental 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 our company's 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 a basic knowledge of theories, practices, and procedures in the Quality Assurance discipline, including the knowledge and understanding of pharmaceutical operations systems.
• Developing technical writing capabilities and is able to compile straightforward investigations and procedures.
• Possesses a basic knowledge and ability to operate information systems required to complete job responsibilities.
• Uses existing procedures to solve routine and standard problems and applies limited judgement and discretion.
• 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.
• Ability to apply statistical methods used in defect resolution and data analysis.
• Accountable for technical contribution to work or project team.
• Requires moderate to little supervision.

• High School Diploma or equivalent.

• 0-3 years of pharmaceutical industry experience required.

• Past Clerical or office administrative experience preferred.

• Adaptability
• Adaptability
• Analytical Instrumentation
• Analytical Method Development
• Analytical Problem Solving
• Bioburden Testing
• Chemical Analysis
• Customer Due Diligence (CDD)
• Customer Service Improvement
• Data Analysis
• Electronic Data Processing
• GMP Compliance
• Information Systems Management
• Karl Fischer Titrations
• Laboratory Instrumentation
• Laboratory Techniques
• Meeting Goals
• Microbiology Research
• Non-Disclosure Agreements
• Performance Feedback
• Pharmaceutical Guidelines
• Quality Assurance (QA)
• Quality Process Development
• Statistical Methods
• Teamwork {+ 2 more}

Current Employees apply HERE

Current Contingent Workers apply HERE

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site…