Address
Form of work Description/Comment: The Quality Assurance Specialist II - Operations is responsible for supporting operations in a GMP Manufacturing Facility. This individual provides oversight of production activities with limited supervision.
II. Essential Functions:
Essential Duties and Responsibilities include the following. Other duties may be assigned.
Oversight (with limited supervision) of production activities, including area clearance, issuance and review of batch records, and making decisions on initiation of Discrepancies
Oversight (with limited supervision), review, and approval of Materials Management and Supply Chain activities
Support of Environmental Monitoring Program for Chelsea Facility, including Controlled Environments and Clean Utilities
Revision and/or review and approval of SOPs, Protocols, Reports, and Master Batch Records for continuous improvement
Initiation of Discrepancies, including Deviations and Investigations.
Support of implementation of CAPA as determined through Discrepancies
Review and approval of Certificates of Analysis for Raw Materials, Intermediates, and Finished Goods
Disposition of controlled materials (Work in Progress, Finished Product, and Raw Materials)
Provide basic support during compliance inspections conducted by external sources (i.e. health authorities)
Support GMP manufacturing shifts as needed, including participation in shift change/floor meetings with the operators
III. Position Requirements:
Education or Equivalent: Bachelor's degree in a scientific discipline is preferred, preferably in physical Science or Chemistry.
Experience:
Minimum of 3-5 years of progressive experience in a GMP environment required.
Minimum of 1 year of Quality Assurance experience in support of GMP production required.
Working knowledge of GMPs and their application to pharmaceutical manufacturing required.
Previous exposure to investigations and product complaints preferred.
Must be able to interpret applicable standards and objectively make decisions with support of management.
Certificates, Licenses, Registrations: None required
Supervisory Responsibilities : None
Knowledge/Skills Requirements:
Computer Skills:
Must be proficient in MS Office Suite.
Experience in the use of Material Requirements Planning (MRP) systems preferred.
Other Skills and Abilities:
Excellent verbal and written communication skills.
Ability to manage both day-to-day operations as well as project work in a fast paced environment.
Ability to work both independently and in a collaborative team setting.
Ability to accept multiple tasks and adjust priorities, as assigned.
Demonstrated ability to stay abreast of trends and new information in the profession.
Excellent organizational skills and attention to detail are required.
Physical Requirements: The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Must have the ability to lift up to 50 pounds.
This position requires minimum travel. Average travel for this position is 5-10% with some variation based upon the demands of business imperatives.
Business Environment:
Fast-paced
Performance Driven
Customer Focused
Collaborative and inclusive
Professional Office Setting
Confidential Department Start Time: 12:00 AM Hours: 8:00am to 5:00pm Location: 123 7555 Harmans Rd. Harmans 52-1667981 Harmans MD 21077 United States Education: Additional Job Details:
II. Essential Functions:
Essential Duties and Responsibilities include the following. Other duties may be assigned.
Oversight (with limited supervision) of production activities, including area clearance, issuance and review of batch records, and making decisions on initiation of Discrepancies
Oversight (with limited supervision), review, and approval of Materials Management and Supply Chain activities
Support of Environmental Monitoring Program for Chelsea Facility, including Controlled Environments and Clean Utilities
Revision and/or review and approval of SOPs, Protocols, Reports, and Master Batch Records for continuous improvement
Initiation of Discrepancies, including Deviations and Investigations.
Support of implementation of CAPA as determined through Discrepancies
Review and approval of Certificates of Analysis for Raw Materials, Intermediates, and Finished Goods
Disposition of controlled materials (Work in Progress, Finished Product, and Raw Materials)
Provide basic support during compliance inspections conducted by external sources (i.e. health authorities)
Support GMP manufacturing shifts as needed, including participation in shift change/floor meetings with the operators
III. Position Requirements:
Education or Equivalent: Bachelor's degree in a scientific discipline is preferred, preferably in physical Science or Chemistry.
Experience:
Minimum of 3-5 years of progressive experience in a GMP environment required.
Minimum of 1 year of Quality Assurance experience in support of GMP production required.
Working knowledge of GMPs and their application to pharmaceutical manufacturing required.
Previous exposure to investigations and product complaints preferred.
Must be able to interpret applicable standards and objectively make decisions with support of management.
Certificates, Licenses, Registrations: None required
Supervisory Responsibilities : None
Knowledge/Skills Requirements:
Computer Skills:
Must be proficient in MS Office Suite.
Experience in the use of Material Requirements Planning (MRP) systems preferred.
Other Skills and Abilities:
Excellent verbal and written communication skills.
Ability to manage both day-to-day operations as well as project work in a fast paced environment.
Ability to work both independently and in a collaborative team setting.
Ability to accept multiple tasks and adjust priorities, as assigned.
Demonstrated ability to stay abreast of trends and new information in the profession.
Excellent organizational skills and attention to detail are required.
Physical Requirements: The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Must have the ability to lift up to 50 pounds.
This position requires minimum travel. Average travel for this position is 5-10% with some variation based upon the demands of business imperatives.
Business Environment:
Fast-paced
Performance Driven
Customer Focused
Collaborative and inclusive
Professional Office Setting
Confidential Department Start Time: 12:00 AM Hours: 8:00am to 5:00pm Location: 123 7555 Harmans Rd. Harmans 52-1667981 Harmans MD 21077 United States Education: Additional Job Details:
