Quality Engineer Pharmaceutical needed! Job #2815
Location: Royston GA
Compensation: Competitive
Relocation: Available
Contract manufacturer to the world's most trusted health and wellness brands looking for a Quality Engineer.
The Quality Engineer is responsible for managing changes to commercial product based on customer requests, process, equipment and facilities improvement/optimization. This individual works collaboratively with customers, corporate and department personnel, and possesses good inter-personal, communication and writing skills. This position is responsible for all quality related activities in planning and implementing changes. This position requires understanding of manufacturing, holding, packaging and testing requirements in a cGMP environment to effectively execute the changes. The position reports to the Associate Director of Quality.
Responsible for managing changes to commercial product based on customer requests, process and equipment optimization, including:
Write/Review/Approve documentation including:
Change control, Deviation and CAPA
Batch Record
Specification & Test Method
Qualification/Validation protocols and reports
SOPs
Training site employees on documentation and/or process relevant to the change or optimization efforts
Collaborates with other departments during planning and implementation activities to ensure timely completion of all identified objectives and milestones
Additional and incidental duties as related to the primary job function as may be required for company purposes from time to time
Possibility of up to 10% domestic US/inter-office travel
Education and Experience:
Minimum of a BS degree in a Science or Engineering discipline, or relevant experience; about 5 years of relevant industry experience
Experience with quality systems and technology transfer within the pharmaceutical industry
Must have thorough understanding of cGMP requirements as they relate to regulatory compliance
Demonstrate technical writing skills
Must possess the understanding of scientific methods and the ability to interpret and communicate data to management, customers and regulatory agencies as required
Other Requirements:
Ability to thrive in a small company environment with sharp cost control focus and a strong sense of urgency
Quality and compliance focus
Cross functional communicator and process facilitator
Ability to be diplomatic, assertive, and skilled in conflict resolution
Creative, flexible, and innovative team player
Highly motivated and proactive leadership orientation
Ability to work in a fast paced, constantly changing work environment
Strong written and verbal communication skills, including effective negotiation techniques
Ability to interact with all levels within the organization and with client contacts
BOTTOM-LINE REQUIREMENTS (Candidates must answer):
1. BS degree in a Science or Engineering discipline preferred.
Answer:
2. 5+ years of quality engineering within the pharmaceutical industry.
Answer:
3. Thorough understanding of cGMP requirements as they relate to regulatory compliance.
Answer:
Please send resume in Word format to andersonrecruiting2@gmail.com as an attachment and include salary, phone number and reference Job #2815. Candidates must also provide responses to the employer's BOTTOM-LINE REEQUIREMENTS which are numbered and listed above!
Location: Royston GA
Compensation: Competitive
Relocation: Available
Contract manufacturer to the world's most trusted health and wellness brands looking for a Quality Engineer.
The Quality Engineer is responsible for managing changes to commercial product based on customer requests, process, equipment and facilities improvement/optimization. This individual works collaboratively with customers, corporate and department personnel, and possesses good inter-personal, communication and writing skills. This position is responsible for all quality related activities in planning and implementing changes. This position requires understanding of manufacturing, holding, packaging and testing requirements in a cGMP environment to effectively execute the changes. The position reports to the Associate Director of Quality.
Responsible for managing changes to commercial product based on customer requests, process and equipment optimization, including:
Write/Review/Approve documentation including:
Change control, Deviation and CAPA
Batch Record
Specification & Test Method
Qualification/Validation protocols and reports
SOPs
Training site employees on documentation and/or process relevant to the change or optimization efforts
Collaborates with other departments during planning and implementation activities to ensure timely completion of all identified objectives and milestones
Additional and incidental duties as related to the primary job function as may be required for company purposes from time to time
Possibility of up to 10% domestic US/inter-office travel
Education and Experience:
Minimum of a BS degree in a Science or Engineering discipline, or relevant experience; about 5 years of relevant industry experience
Experience with quality systems and technology transfer within the pharmaceutical industry
Must have thorough understanding of cGMP requirements as they relate to regulatory compliance
Demonstrate technical writing skills
Must possess the understanding of scientific methods and the ability to interpret and communicate data to management, customers and regulatory agencies as required
Other Requirements:
Ability to thrive in a small company environment with sharp cost control focus and a strong sense of urgency
Quality and compliance focus
Cross functional communicator and process facilitator
Ability to be diplomatic, assertive, and skilled in conflict resolution
Creative, flexible, and innovative team player
Highly motivated and proactive leadership orientation
Ability to work in a fast paced, constantly changing work environment
Strong written and verbal communication skills, including effective negotiation techniques
Ability to interact with all levels within the organization and with client contacts
BOTTOM-LINE REQUIREMENTS (Candidates must answer):
1. BS degree in a Science or Engineering discipline preferred.
Answer:
2. 5+ years of quality engineering within the pharmaceutical industry.
Answer:
3. Thorough understanding of cGMP requirements as they relate to regulatory compliance.
Answer:
Please send resume in Word format to andersonrecruiting2@gmail.com as an attachment and include salary, phone number and reference Job #2815. Candidates must also provide responses to the employer's BOTTOM-LINE REEQUIREMENTS which are numbered and listed above!