Operations Support Specialist

Operations Support Specialist
Support manufacturing, review documentation, ensure GMP compliance, and assist with quality improvements in a biotech environment.

Job #136226

Manufacturing

Birmingham, Alabama

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Talascend is currently seeking an Operations Support Specialist for a contract opportunity with our client in Birmingham, Alabama.

Overview


This role involves supporting manufacturing processes, reviewing production documentation, performing batch record reviews, and ensuring compliance with quality standards. The position requires adherence to GMP practices and supporting continuous improvement initiatives within the facility.


Responsibilities

• Provide support room clearance prior to and during manufacturing
• Review production campaigns documentation for products
• Perform batch record review and final disposition of finished product
• Review data and perform raw material and fill/finish component disposition
• Review clean room logbooks
• Review data to support the testing of site utilities (e.g., WFI, steam, nitrogen, etc.)
• Update, review, and/or approve QMS documentation in document control system (Regulus), such as SOPs, work instructions, forms, and specifications
• Provide on-the-floor support during manufacturing campaigns for PDS Products, PDS Services, and MDS
• Provide on-call support during manufacturing operations
• Issue product labels and perform label reconciliation
• Review inspection plans in SAP
• Conduct GMP monthly monitoring of the facility, including labs, manufacturing, and warehouse areas
• Support deviation and change control activities by completing records, assisting with investigations, and reviewing or approving records and effectiveness checks
• Participate in product quality and system improvement activities
• Assist in gathering and analyzing data to identify opportunities for quality improvement

Qualifications

• High school diploma or equivalent required; 2+ years of experience in a manufacturing or quality assurance environment preferred
• Knowledge of GMP regulations and manufacturing processes
• Strong attention to detail and organizational skills
• Excellent communication and teamwork abilities

Preferred Qualifications

• Experience with SAP or similar ERP systems
• Previous experience in a biotech or pharmaceutical manufacturing setting

We thank all applicants for their interest. However, only those qualified individuals who closely meet the qualifications of the position will be contacted. The details of the position are only a summary, other duties may be assigned as necessary.


Background Check and Drug Screen may be required.