SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
- Title: Manufacturing Specialist
- Location: Harmans, MD
- Industry: Pharmaceutical
- Hours: Mon-Fri 8AM - 5PM
- Salary: $45.67hr (Paid Weekly - Benefits Available)
- Employment Type: 3 month Contract
The Manufacturing Specialist will provide support for Manufacturing Management and Associates to meet batch record review/disposition schedule to adhere to lot release dates. The Specialist 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.
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.
Education or Equivalent:
Bachelor s degree in a science or engineering field
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)
Previous experience operating equipment such as: incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment
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 English.