Type:

full-time

Job Description:

Job Title:

QC Specialist III -

Documentation Location:

Portsmouth, NH Pay Range:

$40-53/hr on W2 Job Summary The QC Specialist III - Documentation is responsible for supporting Quality Control documentation activities, with a primary focus on chemical raw material specifications . The role involves managing and updating specifications through Document Management Systems (DMS) and Laboratory Information Management Systems (LIMS) . The ideal candidate will have experience in a regulated or GMP environment, strong technical writing and document control skills, and knowledge of compendial standards such as USP and EP . This individual will ensure the accuracy, functionality, and compliance of raw material specifications supporting site production. Key Responsibilities Manage updates to raw material specifications initiated through compliance records, management requests, or other approved change requests. Collaborate closely with Raw Material Scientists and Coordinators to develop and maintain accurate and effective testing specifications. Create and update LIMS templates for new and existing raw material specifications. Communicate clearly with cross-functional stakeholders regarding specification changes and compliance-related activities. Ensure specification changes are accurately documented, reviewed, and effectively implemented. Own and maintain specification documents, as well as applicable SOPs and Work Instructions . Apply Data Integrity principles in accordance with Lonza policies, procedures, and guidelines. Support document control and document change management activities. Ensure compliance with applicable cGMP, quality, and regulatory requirements . Perform other duties and responsibilities as assigned. Required Qualifications Education Associate's degree in Science required. A combination of relevant education and professional experience may be considered. Experience Minimum 2 years of experience in document editing, technical documentation, document control, or a regulated industry. Experience working in a GMP, pharmaceutical, biotechnology, or other regulated environment preferred.

Entry-level experience range:

0-4 years . Required Skills & Qualifications Advanced proficiency in Microsoft Office Suite , particularly Microsoft Word and Excel . Excellent proofreading and editing skills. Experience with Document Management Systems (DMS) and document control practices. Experience with document change management .

Technical writing experience involving:

Protocols Reports Specifications Analytical methods Experience with LIMS and computerized management systems. Knowledge of compendial standards such as USP, EP, and other applicable pharmacopeias . Strong understanding of cGMP and Data Integrity principles . Ability to interpret written and verbal instructions accurately. Strong organizational, communication, and cross-functional collaboration skills. Ability to manage multiple priorities and meet deadlines in a fast-paced environment. Key Competencies Agility Ability to learn quickly and apply knowledge to improve processes. Comfortable adapting to changing priorities and working with multiple internal and external customers. Business Acumen Understands business priorities and supports organizational objectives. Identifies opportunities to improve and streamline processes. Collaboration Works effectively with internal customers and cross-functional teams. Listens to and respects ideas and perspectives from others. Customer Focus Understands stakeholder needs and delivers high-quality results. Works collaboratively to ensure customer and business requirements are met. Driving Results Follows up on projects to ensure deadlines and deliverables are met. Maintains a high level of quality and accuracy. Demonstrates strong technical writing capabilities. Leadership Takes ownership of assignments and drives work through completion. Key Stakeholders Quality Control Management Quality Assurance - Raw Materials Part Number Team Raw Material Scientists Raw Material Coordinators Cross-functional Quality and Manufacturing teams Quality & Safety Responsibilities Ensure the highest standards of quality in all aspects of work. Follow applicable cGMP requirements at all times. Take ownership of the quality of work and promptly communicate quality concerns, deviations, deficiencies, or potential compliance issues. Follow all company and site safety procedures. Participate in safety initiatives and promptly report actual or potential accidents and injuries.

Work Environment & Physical Requirements Work Environment:

Office setting

Mental Demands:

Ability to work in a busy operational environment with tight deadlines and high workloads.

May require occasional:

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