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Manufacturing Technical Writer

Company: BCVS Group inc.
Location: Baltimore
Posted on: November 26, 2022

Job Description:

Position: QA Specialist/Technical writer

Duration: Long-Term

Location: Baltimore, MD( On-Site)

Specific Tasks, Duties and Responsibilities:

--- Initiates Quality Records and conducts deviation investigations that meeting both Industry and client expectations
--- 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.

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

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

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)

Job Type: Contract

Salary: From $40.00 per hour

Schedule:
* 5x8
* 8 hour shift

People with a criminal record are encouraged to apply

Ability to commute/relocate:
* Baltimore, MD 21218: Reliably commute or planning to relocate before starting work (Required)

Experience:
* Pharmacutical: 5 years (Required)

Work Location: One location

*Speak with the employer*
+91 +1571-685-2793%58047475%

Keywords: BCVS Group inc., Baltimore , Manufacturing Technical Writer, Other , Baltimore, Maryland

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