The Associate Quality Assurance Specialist is responsible for supporting Quality Assurance operations.

Primary duties include record review, learning commercial workflows and supporting activites – may include interaction with partner.

Required Skills

+--------------------------------------------------------------------------+ | An employee in this position must be able to perform the essential job | | functions listed below with or without reasonable accommodation. The | | Company will make reasonable accommodation for a qualified individual | | with a disability to enable the qualified individual to perform | | essential job functions. | | | | Quality Assurance has multiple areas of responsibilities which may | | include Operations, Compliance, Systems, and Regulatory Affairs. Each | | team member may be asked to focus on one area or work within multiple | | areas of Quality Assurance. | | | | Uses technical, regulatory, and cGMP knowledge to provide oversight to | | the Manufacturing Operations, for both commercial and development | | projects. | | - Review executed operations records. Identify and report any errors | | or omissions. | | - Provide troubleshooting and guidance to manufacturing shop floor | | employees on quality issues. | | - Review documentation and release raw materials, WIP, and finished | | goods to next processing stage. | | - Participates as a team member in investigations (DEV, CA/PA). | | - Assemble and issue batch records to Manufacturing. | | | | Ability to meet physical demands and perform the essential job functions | | within the work environment identified in this job description. | | Nothing in this job description restricts management’s right to assign | | or reassign duties and responsibilities to this job at any time. | |   | | | | +----------------------------------------------------------------------- | | ---+ | | | PHYSICAL DEMANDS AND WORK ENVIRONMENT: | | | | | | | | | | | | The physical demands and work environment characteristics described he | | re | | | | 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 qualified individuals with | | | | | | disabilities to perform essential functions. | | | | | | | | | | | | - Physical Demands: | | | | | | | | | | | |   | | | | | | | | | | | | While performing the duties of this job, the employee must be able to: | | | | | | | | | | | | - Remain in a stationary position extended periods of time, whether | | | | | | sitting or standing, and be able to move about inside the office t | | o | | | | access file cabinets, office machinery, etc. | | | | | | - Operate a computer and other office productivity machinery, such a | | s | | | | a calculator, copy machine and computer printer. | | | | | | - Communicate and exchange information with team members and other | | | | | | internal personnel and must be able to effectively communicate | | | | | | accurate information with external contacts. | | | | | | - Occasionally move and/or lift objects up to 25 pounds. | | | | | | - Occasionally climb stairs, bend, squat, kneel, crouch, and reach i | | n | | | | any direction including above the shoulder to access materials | | | | | | and/or documentation. | | | | | | | | | | | |  Work Environment: | | | | | | | | | | | | - While performing the duties of this job, the employee is regularly | | | | | | working in a typical interior/office work environment. | | | | | | - Requires wearing OSHA and FDA approved protective and safety | | | | | | equipment in designated areas. | | | | | | - Position may involve extended work hours. | | | | | | - The noise level in the work environment is usually moderate. | | | | | | | | | | | |   | | | | | +----------------------------------------------------------------------- | | ---+ | +--------------------------------------------------------------------------+

Required Experience

1+ years pharmaceutical experience is preferred.

+--------------------------------------------------------------------------+ | An employee in this position must be able to perform the essential job | | functions listed below with or without reasonable accommodation. The | | Company will make reasonable accommodation for a qualified individual | | with a disability to enable the qualified individual to perform | | essential job functions. | | | | Quality Assurance has multiple areas of responsibilities which may | | include Operations, Compliance, Systems, and Regulatory Affairs. Each | | team member may be asked to focus on one area or work within multiple | | areas of Quality Assurance. | | | | Uses technical, regulatory, and cGMP knowledge to provide oversight to | | the Manufacturing Operations, for both commercial and development | | projects. | | - Review executed operations records. Identify and report any errors | | or omissions. | | - Provide troubleshooting and guidance to manufacturing shop floor | | employees on quality issues. | | - Review documentation and release raw materials, WIP, and finished | | goods to next processing stage. | | - Participates as a team member in investigations (DEV, CA/PA). | | - Assemble and issue batch records to Manufacturing. | | | | Ability to meet physical demands and perform the essential job functions | | within the work environment identified in this job description. | | Nothing in this job description restricts management’s right to assign | | or reassign duties and responsibilities to this job at any time. | |   | | | | +----------------------------------------------------------------------- | | ---+ | | | PHYSICAL DEMANDS AND WORK ENVIRONMENT: | | | | | | | | | | | | The physical demands and work environment characteristics described he | | re | | | | 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 qualified individuals with | | | | | | disabilities to perform essential functions. | | | | | | | | | | | | - Physical Demands: | | | | | | | | | | | |   | | | | | | | | | | | | While performing the duties of this job, the employee must be able to: | | | | | | | | | | | | - Remain in a stationary position extended periods of time, whether | | | | | | sitting or standing, and be able to move about inside the office t | | o | | | | access file cabinets, office machinery, etc. | | | | | | - Operate a computer and other office productivity machinery, such a | | s | | | | a calculator, copy machine and computer printer. | | | | | | - Communicate and exchange information with team members and other | | | | | | internal personnel and must be able to effectively communicate | | | | | | accurate information with external contacts. | | | | | | - Occasionally move and/or lift objects up to 25 pounds. | | | | | | - Occasionally climb stairs, bend, squat, kneel, crouch, and reach i | | n | | | | any direction including above the shoulder to access materials | | | | | | and/or documentation. | | | | | | | | | | | |  Work Environment: | | | | | | | | | | | | - While performing the duties of this job, the employee is regularly | | | | | | working in a typical interior/office work environment. | | | | | | - Requires wearing OSHA and FDA approved protective and safety | | | | | | equipment in designated areas. | | | | | | - Position may involve extended work hours. | | | | | | - The noise level in the work environment is usually moderate. | | | | | | | | | | | |   | | | | | +----------------------------------------------------------------------- | | ---+ | +--------------------------------------------------------------------------+