**MUST HAVE STRONG TECHNICAL WRITING SKILLS**
The Quality Specialist serves as the Technical Writer in the Quality Control department and is responsible for creating or revising laboratory test monographs, protocols, reports, SOP’S and investigations in the electronic documentation (Master Control/TrackWise)systems. Interacts frequently with Departmental leaders to provide perspective on timing of document needs such as test methods, specifications and controlled documents, change control, and FDA filings. Works collaboratively with Manufacturing/Pharm Tech/R&D and Regulatory affairs for revisions to records. May also participate in project teams for new product introductions.
Collaborations & Management of Manufacturing Batch Records
§ Works collaboratively with Manufacturing/Pharm Tech/R&D and Regulatory affairs for revisions to revising laboratory test monographs, protocols, reports, SOP’s and investigation records.
§ Interacts frequently with Departmental leaders to provide perspective on timing of test methods, specifications and controlled documents, change control, and FDA filings.
§ Maintains a schedule for completion of documents.
§ Revises records using the current validated EDMS/TrackWise and ensure consistency across the groups in laboratory.
§ Provides timely support and direction to the team and/or other departments in creating or updating Master P Records.
§ Maintains awareness to the document control needs of the Manufacturing department and other departments in order to meet scheduling needs.
§ Mutual Accountability to review and propose revisions to laboratory records and SOP's as required.
§ Identifies compliance risks to management, provides remediation proposals, and supports solution implementation for document control issues.
§ Provides compliance support, expertise, and training for all impacted departments.
§ Performs self-check audits and immediate support for regulatory audits.
§ Participates in the development of standard work practices and/or SOPs to ensure high and consistent level of quality.
§ Writes and revises SOPs as necessary.
§ Mutual accountability with other departmental leadership to improve document control and implement electronic database management systems (EDMS).
§ Participates in site quality improvement teams.
§ Seeks out improved EDMS systems for future use.
§ BS degree in Chemistry, Biology or Pharmaceutical Sciences with 3+ years’ experience in a pharmaceutical manufacturing environment including a minimum of 2 years in Quality/laboratory.
§ Knowledge of all current state, federal and local standards and regulations, e.g., cGMP, OSHA, and DEA.
§ Knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines.
§ Technical and quality background related to pharmaceuticals.
§ Working knowledge of electronic batch record systems.
§ Strong communication skills.
§ Strong focus on quality and proven ability to apply a high degree of integrity.
§ Customer/Stakeholder focused (understand business plans and operating environment).
§ Demonstrated skills in document control and EDMS/TrackWise systems.
§ Strong technical writing ability.
§ Clear problem-solving and decision-making skill.