Job Summary
- Location
- Center Valley, PA 18034
- Industries
- Biotechnology/Pharmaceuticals
- Job Type
- Full Time
- Employee
- Career Level
- Experienced (Non-Manager)
- Job Reference Code
- 1425
Sr. QA Associate - NOVOCART Division / 1425
About the Job
Aesculap is the largest worldwide supplier of surgical instruments and implants for all disciplines including neurosurgery, microsurgery, ENT, plastic and reconstructive, thoracic, micro-vascular, cardiovascular, orthopedic, laparascopic, general surgeries and central processing. We were founded in Germany in 1867 and have been in operation in the U.S. since 1977. Our U.S. corporate office is located in Center Valley, Pennsylvania.
Position Description:
Aesculap is the largest worldwide supplier of surgical instruments and implants for all disciplines including spine, neurosurgery, microsurgery, ENT, plastic and reconstructive, thoracic, micro-vascular, cardiovascular, orthopedic, laparascopic, general surgeries and central processing. We were founded in Germany in 1867 and have been in operation in the U.S. since 1977. Our U.S. corporate office is located in Center Valley, Pennsylvania. Aesculap, Inc., has an excellent opportunity for a Sr. Quality Assurance Associate within our NovoCart Division.
SUMMARY:
Responsible for maintaining quality systems and monitoring compliance to standard operating procedures (SOPs) and Quality System regulations.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Conducts finished product and in-process release activities and batch record reviews, including product release and reviewing all supporting documentation
• Reviews supporting documents and approves incoming material according to inspection specifications
• Performs internal audit to include all aspects of company GMP functions/operations and support areas to ensure compliance to cGMPs, quality standards and updated regulatory guidelines and AIS policies and procedures
• Performs external audits of raw material suppliers, contract manufacturers, packagers, contract laboratories and contract research organizations to evaluate processes, systems and procedures for compliance to cGMP/GLP requirements
• Monitors and tracks quality systems deviations,and facilitates the execution of corrective actions and preventive actions (CAPA).
• Investigates product complaints.
• Reviews SOPs, IQ/OQ/PQs, batch records and other formal written procedures for accuracy, consistency and compliance with relevant guidelines
• Develops technical documents and operating procedures including SOPs, work instructions, audit reports, investigations, etc.
• Facilitates the establishment of new product specifications,and process and product improvements with Quality Assurance Manager
• Represents Quality Assurance in design review and new product development
• Ensures training is performed and documented according to the compliance guidelines
• Ensures the required validation protocols are performed and reported according to established guidelines
• Facilitates Agency inspections or assisting the primary regulatory escort with the preparation of government inspections
• Other duties may be assigned.
• This position may be exposed to potentially contaminated instruments and blood or other bodily fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, AIS will provide a safe working environment for all employees
SUPERVISORY RESPONSIBILITIES:
Not Applicable.
QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION/EXPERIENCE:
B.S. degree with 3-5 years of quality assurance experience in cell therapy/biopharmaceutical industry
KNOWLEDGE/SKILLS
• Thorough knowledge of cGMPs/GLPs and regulatory requirements is essential
• Auditing and/or validation experience desired
• Requires good working knowledge and experience with a document control system.
• Must have ability to process, analyze and present data
• Computer skills in spreadsheets, word processing and databases desired
• Excellent oral and written communication skills required
• Must have strong organizational skills.
• Must be detail oriented
• Must be able to work independently
LANGUAGE AND MATHEMATICAL SKILLS; REASONING ABILITY:
Language Skill: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
Aesculap offers an excellent benefits package, which includes healthcare, a 401(k) plan, company sponsored pension and tuition reimbursement. To learn more about Aesculap and our products, please visit us on the internet at www.aesculapimplantsystems.com . An EOE.
Position Description:
Aesculap is the largest worldwide supplier of surgical instruments and implants for all disciplines including spine, neurosurgery, microsurgery, ENT, plastic and reconstructive, thoracic, micro-vascular, cardiovascular, orthopedic, laparascopic, general surgeries and central processing. We were founded in Germany in 1867 and have been in operation in the U.S. since 1977. Our U.S. corporate office is located in Center Valley, Pennsylvania. Aesculap, Inc., has an excellent opportunity for a Sr. Quality Assurance Associate within our NovoCart Division.
SUMMARY:
Responsible for maintaining quality systems and monitoring compliance to standard operating procedures (SOPs) and Quality System regulations.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Conducts finished product and in-process release activities and batch record reviews, including product release and reviewing all supporting documentation
• Reviews supporting documents and approves incoming material according to inspection specifications
• Performs internal audit to include all aspects of company GMP functions/operations and support areas to ensure compliance to cGMPs, quality standards and updated regulatory guidelines and AIS policies and procedures
• Performs external audits of raw material suppliers, contract manufacturers, packagers, contract laboratories and contract research organizations to evaluate processes, systems and procedures for compliance to cGMP/GLP requirements
• Monitors and tracks quality systems deviations,and facilitates the execution of corrective actions and preventive actions (CAPA).
• Investigates product complaints.
• Reviews SOPs, IQ/OQ/PQs, batch records and other formal written procedures for accuracy, consistency and compliance with relevant guidelines
• Develops technical documents and operating procedures including SOPs, work instructions, audit reports, investigations, etc.
• Facilitates the establishment of new product specifications,and process and product improvements with Quality Assurance Manager
• Represents Quality Assurance in design review and new product development
• Ensures training is performed and documented according to the compliance guidelines
• Ensures the required validation protocols are performed and reported according to established guidelines
• Facilitates Agency inspections or assisting the primary regulatory escort with the preparation of government inspections
• Other duties may be assigned.
• This position may be exposed to potentially contaminated instruments and blood or other bodily fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, AIS will provide a safe working environment for all employees
SUPERVISORY RESPONSIBILITIES:
Not Applicable.
QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION/EXPERIENCE:
B.S. degree with 3-5 years of quality assurance experience in cell therapy/biopharmaceutical industry
KNOWLEDGE/SKILLS
• Thorough knowledge of cGMPs/GLPs and regulatory requirements is essential
• Auditing and/or validation experience desired
• Requires good working knowledge and experience with a document control system.
• Must have ability to process, analyze and present data
• Computer skills in spreadsheets, word processing and databases desired
• Excellent oral and written communication skills required
• Must have strong organizational skills.
• Must be detail oriented
• Must be able to work independently
LANGUAGE AND MATHEMATICAL SKILLS; REASONING ABILITY:
Language Skill: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
Aesculap offers an excellent benefits package, which includes healthcare, a 401(k) plan, company sponsored pension and tuition reimbursement. To learn more about Aesculap and our products, please visit us on the internet at www.aesculapimplantsystems.com . An EOE.
