Responsibilities
Works in GMP environment and ensures regulatory compliance.
Perform Manufacturing activities including:
Performs a variety of complex tasks in accordance with cGMP, cGDP, SOPs, and Batch Records
Batch Documentation/Record Generation
Materials sampling, staging, dispensing, and return
Equipment and Room set-up, operation, and cleaning
Use of appropriate personal safety equipment and engineering controls
In-process inspection and sampling
Support investigational and quality systems activities
Assist maintenance in the performance of preventative maintenance activities, troubleshooting and repair of equipment
Participate in continuous improvement activities
Interfaces and consults with other functions, such as process development, Quality Control and Quality Assurance
Initiates deviations, assists in assessing product quality impact and assists with proposals for Corrective and Preventive Actions (CAPAs)
Writes and reviews SOPs and other applicable cGMP documentation for Manufacturing
Ensures proper execution of Master Batch Records, standard operating procedures, and validation protocols
Ensures completion of equipment logs and batch records
Ensures cleanliness and proper assembly of manufacturing equipment and manufacturing areas per approved procedures (SOP’s)
Ensures accuracy of Standard Operating Procedures (SOP’s)
Trains on and understand all policy and procedures including Regulatory, Safety, SOPs, Work Instructions, etc.
Operate to the highest ethical and moral standards.
Comply with Abzena's policies and procedures.
Communicate effectively with clients, supervisors, colleagues and staff.
Participate effectively as a team player in all aspects of Abzena's business.
Adhere to quality standards set by regulations and Abzena policies, procedures, and mission.
Perform other duties as assigned.
Qualifications
- Bachelor’s degree in chemistry, biology or engineering.
A minimum of 2 years’ experience in a GMP pharmaceutical environment preferred
Experience with cGMP manufacturing operations and GxP principles.
Understanding and application of cGMP requirements.
Physical Requirements
- Ability to stand for 3-4 hours at a time, sit for 1 to 2 hours at a time.
- Frequently lift and or move objects up to 30 pounds.
- Stand/walk during entire length of shift.
- Use arms, hands and fingers to handle, feel or reach.
- Ability to climb, balance, stoop, kneel, crouch, or crawl.
- Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.
FLSA: Non-Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
This job description requires the handling, supervision, management, or otherwise exposure to RCRA hazardous waste as defined at 40 CFR (Code of Federal Regulations), parts 239 – 289.
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