Sharp Corporation
Sr. Specialist, Quality Assurance
Sharp Corporation, Bethlehem, Pennsylvania, United States, 18020
SUMMARY
The Senior Specialist, QA Analytical ensures cGMP compliance and adherence to SOPs and WRKIs through the review and approval of compliance documentation. It also ensures company compliance in its programs to prevent or eliminate deviations in procedures. Additional responsibilities include review and approval of investigations, CAPAs, analytical lab documents, regulatory support and quality process improvement.
ESSENTIAL DUTIES AND RESPONSIBILITIESProvide leadership, support and oversight of analytical lab documents, investigations, CAPAs, manufacturing, packaging, labels, release of material.Responsible for review and approval of analytical CoAs, reports, stability protocols, calibration notebooks and method transfers/development testing protocols.Responsible for the review, approval and logistics of pre-executed and post executed batch records through QA department.Review and approve documents, such as change control, change orders, component specification sheets to ensure proper quality and compliance standards are met.Review technical problems, procedures, complaints and non-conformance of departments, materials and processes.Prepare Annual Product Review (APR) reports in compliance with FDA and EU regulations.Prepare written reports with recommendations for corrective and preventative actions to problems and changes to procedures to ensure high quality is the company standard.Review and update SOPs, policies and processes regularly to ensure all quality standards are in compliance with cGMP standards, FDA and all competent authority regulations and requirements.Track, monitor and analyze key performance indicators (KPIs). Develop and maintain KPIs for batch record review right first time and error tracking.Participate/Lead in internal audits and/or supplier audits per schedule and review the results of audits to ensure resolution of any noted deviations.Assist to write up of audit findings and reports and generation of CAPAs related to audit findings.Responsible for the review and approval for third party manufacturing instruction and the disposition approvals.Review technical, regulatory publications, articles, and abstracts to stay abreast of new quality/technical developments in industry.Assist with the review execution of validation protocols and equipment qualifications.Adhere to set safety standards.Achieve expected performance measures.Other duties as assigned.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.
Bachelor's degree in technical discipline (BS/BA) from a four-year college or university preferred with four to seven years related experience and or training; or equivalent combination of education and experience.4 - 7 years in pharmaceutical or biotech manufacturing in a Quality or Compliance role.Experience in analytical chemistry, compliance, and technical writing.Demonstrated ability to work independently, handle multiple tasks simultaneously and negotiate and meet critical timelines.Excellent oral and written communication is required to communicate with the team, peers, management and external contacts.Proficient with interpreting and implementing cGMPs, FDA & DEA Regulations and CFRs.Leadership skill to mentor and develop team to achieve company goals.Strong working knowledge of personal computers and Microsoft Office Products, including Word, Project and Excel.
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.
While performing the duties of this job, the employee is frequently required to stand, walk and sit and regularly required to talk or hear. Employee is occasionally required to walk use hands to finger, handle or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include color vision.
ENVIRONMENTAL CONDITIONS
While performing the duties of the job, the employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals and working near moving mechanical parts. The noise level in the work environment is usually quiet.
The Senior Specialist, QA Analytical ensures cGMP compliance and adherence to SOPs and WRKIs through the review and approval of compliance documentation. It also ensures company compliance in its programs to prevent or eliminate deviations in procedures. Additional responsibilities include review and approval of investigations, CAPAs, analytical lab documents, regulatory support and quality process improvement.
ESSENTIAL DUTIES AND RESPONSIBILITIESProvide leadership, support and oversight of analytical lab documents, investigations, CAPAs, manufacturing, packaging, labels, release of material.Responsible for review and approval of analytical CoAs, reports, stability protocols, calibration notebooks and method transfers/development testing protocols.Responsible for the review, approval and logistics of pre-executed and post executed batch records through QA department.Review and approve documents, such as change control, change orders, component specification sheets to ensure proper quality and compliance standards are met.Review technical problems, procedures, complaints and non-conformance of departments, materials and processes.Prepare Annual Product Review (APR) reports in compliance with FDA and EU regulations.Prepare written reports with recommendations for corrective and preventative actions to problems and changes to procedures to ensure high quality is the company standard.Review and update SOPs, policies and processes regularly to ensure all quality standards are in compliance with cGMP standards, FDA and all competent authority regulations and requirements.Track, monitor and analyze key performance indicators (KPIs). Develop and maintain KPIs for batch record review right first time and error tracking.Participate/Lead in internal audits and/or supplier audits per schedule and review the results of audits to ensure resolution of any noted deviations.Assist to write up of audit findings and reports and generation of CAPAs related to audit findings.Responsible for the review and approval for third party manufacturing instruction and the disposition approvals.Review technical, regulatory publications, articles, and abstracts to stay abreast of new quality/technical developments in industry.Assist with the review execution of validation protocols and equipment qualifications.Adhere to set safety standards.Achieve expected performance measures.Other duties as assigned.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.
Bachelor's degree in technical discipline (BS/BA) from a four-year college or university preferred with four to seven years related experience and or training; or equivalent combination of education and experience.4 - 7 years in pharmaceutical or biotech manufacturing in a Quality or Compliance role.Experience in analytical chemistry, compliance, and technical writing.Demonstrated ability to work independently, handle multiple tasks simultaneously and negotiate and meet critical timelines.Excellent oral and written communication is required to communicate with the team, peers, management and external contacts.Proficient with interpreting and implementing cGMPs, FDA & DEA Regulations and CFRs.Leadership skill to mentor and develop team to achieve company goals.Strong working knowledge of personal computers and Microsoft Office Products, including Word, Project and Excel.
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.
While performing the duties of this job, the employee is frequently required to stand, walk and sit and regularly required to talk or hear. Employee is occasionally required to walk use hands to finger, handle or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include color vision.
ENVIRONMENTAL CONDITIONS
While performing the duties of the job, the employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals and working near moving mechanical parts. The noise level in the work environment is usually quiet.