Vacancy expired!
Apex Systems is seeking a Quality Engineering Technical Writer in Harmans MD.
Position: Quality Systems Technical Writer Location: Harmans, MD Contract: 3 months Position Overview: This role is responsible for providing support to our clients Quality Systems to ensure compliance with applicable EU regulations, guidance's, industry standards and Client policies/procedures supporting the Phase I/II/III clinical and commercial GMP manufacturing of biological drug substance and drug product. The position will provide specific support by owning/authoring deviations primarily and driving continuous improvement through CAPA initiation and closure that may include updating/revising GMP documents Specific Tasks, Duties and Responsibilities:- Owns Quality Records and conducts deviation investigations that meet both Industry and Client expectations
- Leads and manages investigation through effective root cause analysis and assesses product and/or facility impact using input from various departments
- Develops, executes CAPAs as required
- Technical knowledge will be required to ensure that product and process understanding is sufficient to investigate deviations, that investigations are technically sound, meet quality expectations, and that corrective actions are effective.
- Revision of documents such as SOPs in support of CAPA may be required.
- Conducts data gathering, trending, and data presentation as needed to support investigations
- Present investigation findings through investigation summary to team when necessary.
- Effective time management to ensure timelines and target expectations are met for both deviations and any assigned CAPA in order to meet company goal and objectives.
- Other duties as assigned
- Familiarity with Good Manufacturing Practices (GMPs) and 21 CFR Parts 210/211 OR Quality System Regulations (QSR) per 21 CFR Part 820
- Exposure to applicable biological regulations (21 CFR Part 600s) or EMA GMPs (Eudralex) a plus
- Knowledgeable on the FDA Guidance for Aseptic Processing and EU Annex 1 for Sterile Medicinal Products
- Awareness of applicable FDA Guidance's, EMA Annex/Guidelines, ICH Guidelines, USP, ISPE, ISO, PDA Technical Reports and other resources and ability to find information when needed.
- Comfortability with using and learning new GMP electronic computerized systems such as for Document Management, Learning Management, Quality Management - Trackwise and Calibration/Maintenance. Familiarity required with Microsoft Office applications including Microsoft Word, Access and Excel.
- Able to work in a team setting and independently under minimum supervision
- Creative individual with excellent trouble shooting skills
- Requires the ability to produce results in a fast-paced environment
- B.S. in a Life Sciences, Engineering or related discipline and 5+ years of relevant experience
- Experience within the biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality Assurance, Quality Control, Environmental Monitoring or Validation function with a strong familiarity of general GMP documentation and Equipment/Instrumentation.
- Experience with aseptic processing
- Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
Vacancy expired!