Perspective Therapeutics, Inc.
Quality Assurance Specialist II
Perspective Therapeutics, Inc., Coralville, Iowa, United States, 52241
Overview
Thanks for visiting our Career Page. Please review our open positions and apply to the positions that match your qualifications. Essential Functions
Write, revise, review, and approve site Standard Operating Procedures. Review Batch Records and provide final product disposition. Review and assess in-house solution preparation and external material testing. Assist with implementation and maintenance of electronic Document Management System. Perform quality review regulatory submission documents. Review and approve documentation of GMP activities performed at contract facilities. Maintain QA records according to applicable regulatory requirements and Perspective policy. Participate in regulatory agency (e.g. FDA) inspections. Investigate or serve as GMP QA reviewer/approver for customer complaints, deviations/out of specifications, ensuring root causes and corrective actions as assigned. Ensure root causes are identified and CAPA is implemented to reduce/prevent recurrence within required timeframes. Document and trend deviations/out of specifications/root causes/CAPAs. Participate in internal audits of GMP Quality Systems and subsystems. Aid in assessing risk during Vendor Qualifications or Material Assessments. Conduct incoming material disposition. Document Control, Training, Quality Systems back-up and key trainer. Review and compile the Annual Product Quality Review. Participate in inspection readiness activities and provide support during regulatory site inspections. 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
Requires a BA/BS degree in Chemistry, Biochemistry, Biological Sciences, or a related field; Master’s degree preferred. Minimum of 3 years of experience in a quality assurance role, preferably within the pharmaceutical or radiopharmaceutical industry. Familiar with radiation safety standards and policies is preferred. Experience with MS Office Suite required. Knowledge / Skill / Ability
Excellent knowledge of GMP, GLP, and GCP requirements. Knowledge of corporate governance, health care regulations, laws, and standards. Strong understanding of quality management systems and GxP to ensure regulatory compliance. Understanding of Computer System Validation/Assurance requirements. Ability to adapt quickly in a fast-paced, dynamic environment. Ability to communicate with and positively influence broad and diverse populations within and outside the organization. Ability to work in a team environment with minimum supervision. Strong collaborative, partnering, and interpersonal skills. Excellent written and oral communication skills. High ethical standards and discretion. Must be able to lift/move materials (e.g., portable equipment, lead, gas cylinders, chemical/waste containers). Flexibility with scheduling requirements may include night shift, overtime, weekends, and holiday coverage. Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must be able to work outside of regular hours, including off shift, weekend, and holiday work as business needs require. Must be willing to work in a facility producing radioactive materials. Employees are required to participate in safety programs to minimize exposure. Must be willing to wear Personal Protective Equipment (PPE) as needed. May be required to sit or stand for long periods. Occasional kneeling, crouching, twisting, bending, stooping, pushing, pulling, or reaching may be required. Good hand-eye coordination and attention to detail. Willingness to complete safety training within allotted timeframes and to work in a team-based environment. Note: This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities. Duties may change at any time with or without notice. Perspective Therapeutics provides equal employment opportunities to all employees and applicants and prohibits discrimination and harassment of any type. This policy applies to all terms and conditions of employment.
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Thanks for visiting our Career Page. Please review our open positions and apply to the positions that match your qualifications. Essential Functions
Write, revise, review, and approve site Standard Operating Procedures. Review Batch Records and provide final product disposition. Review and assess in-house solution preparation and external material testing. Assist with implementation and maintenance of electronic Document Management System. Perform quality review regulatory submission documents. Review and approve documentation of GMP activities performed at contract facilities. Maintain QA records according to applicable regulatory requirements and Perspective policy. Participate in regulatory agency (e.g. FDA) inspections. Investigate or serve as GMP QA reviewer/approver for customer complaints, deviations/out of specifications, ensuring root causes and corrective actions as assigned. Ensure root causes are identified and CAPA is implemented to reduce/prevent recurrence within required timeframes. Document and trend deviations/out of specifications/root causes/CAPAs. Participate in internal audits of GMP Quality Systems and subsystems. Aid in assessing risk during Vendor Qualifications or Material Assessments. Conduct incoming material disposition. Document Control, Training, Quality Systems back-up and key trainer. Review and compile the Annual Product Quality Review. Participate in inspection readiness activities and provide support during regulatory site inspections. 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
Requires a BA/BS degree in Chemistry, Biochemistry, Biological Sciences, or a related field; Master’s degree preferred. Minimum of 3 years of experience in a quality assurance role, preferably within the pharmaceutical or radiopharmaceutical industry. Familiar with radiation safety standards and policies is preferred. Experience with MS Office Suite required. Knowledge / Skill / Ability
Excellent knowledge of GMP, GLP, and GCP requirements. Knowledge of corporate governance, health care regulations, laws, and standards. Strong understanding of quality management systems and GxP to ensure regulatory compliance. Understanding of Computer System Validation/Assurance requirements. Ability to adapt quickly in a fast-paced, dynamic environment. Ability to communicate with and positively influence broad and diverse populations within and outside the organization. Ability to work in a team environment with minimum supervision. Strong collaborative, partnering, and interpersonal skills. Excellent written and oral communication skills. High ethical standards and discretion. Must be able to lift/move materials (e.g., portable equipment, lead, gas cylinders, chemical/waste containers). Flexibility with scheduling requirements may include night shift, overtime, weekends, and holiday coverage. Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must be able to work outside of regular hours, including off shift, weekend, and holiday work as business needs require. Must be willing to work in a facility producing radioactive materials. Employees are required to participate in safety programs to minimize exposure. Must be willing to wear Personal Protective Equipment (PPE) as needed. May be required to sit or stand for long periods. Occasional kneeling, crouching, twisting, bending, stooping, pushing, pulling, or reaching may be required. Good hand-eye coordination and attention to detail. Willingness to complete safety training within allotted timeframes and to work in a team-based environment. Note: This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities. Duties may change at any time with or without notice. Perspective Therapeutics provides equal employment opportunities to all employees and applicants and prohibits discrimination and harassment of any type. This policy applies to all terms and conditions of employment.
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