Job description

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Job description - QA Specialist, Manufacturing Technical Writer

Location: Baltimore, MD

Must: EAD

The "QA Specialist, Manufacturing Technical Writer will be responsible for executing root cause investigations, owning/authoring deviations, driving continuous improvement efforts and other quality report types, and revising GMP documents such as SOPs and Manufacturing batch records.

Specific Tasks, Duties and Responsibilities: • Initiates Quality Records and conducts deviation investigations that meeting both Industry and client expectations

• Leads or manage investigations including root cause analysis and assesses product impact using input from various departments

• Develops executes and oversees CAPAs

• Technical leadership 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.

• Supports Tech transfer and process monitoring support as needed • Works with the team to monitor critical process parameters • Revision and management of manufacturing documents such as Batch Records and SOPs • Leads or supports Continuous Improvement projects • Conducts data gathering, trending, and data presentation as needed to support investigations • Responsible for real-time, on the floor response in support of operational deviations by gathering information and completing an initial event report. Essential Skills and Experience: Education or Equivalent: • Bachelor’s degree in a science or engineering field Experience: • 5+ years of demonstrated technical competency in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field) Knowledge/Skills Requirements: • Previous experience in process deviation investigations and remediation • Previous experience authoring and/or revising technical documents • Demonstrated ability to work effectively cross-functionally • Excellent communication and technical writing skills • Ability to support and/or lead system troubleshooting efforts • Familiar with Lean Six Sigma Methodologies and proven analytical/problem-solving capabilities

• Ability to “get the job done” and take responsibility for results without direct authority; ability to coordinate, facilitate and organize resources.

• Superior customer service orientation with strong follow-up skills and attention to detail.

• Advanced PC skills, knowledge of company-specific software packages • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, financial reports and legal documents.

• Demonstrated ability to read, write, and speak clear

• Experience using Trackwise@

Job Types: Full-time, Contract

Salary: From $30.00 per hour

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Baltimore, MD 21201: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Microsoft Powerpoint: 1 year (Preferred)

Work Location: One location

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