The Quality Assurance Specialist II will support the design, implementation and maintenance of QA and compliance programs including, but not limited to an SOP system and corrective action and preventative actions (CAPAs). In addition, the Quality Assurance Specialist II will provide consultation in the interpretation of good manufacturing practice (GMP), good laboratory practice (GLP), and good clinical practice (GCP) regulations, guidelines, policies, and procedures. These responsibilities involve working closely with multiple departmental teams across the compan

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.
• Participates in regulatory agency (i.e. FDA, etc.) 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 appropriately 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 sub systems.
• Aid in assessing risk during Vendor Qualifications or Material Assessments.
• Conducts 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

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 compliance with regulatory requirements.
• 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 required.
• Strong collaborative, partnering, and interpersonal skills.
• Excellent communication skills, both written and oral.
• High ethical standards, trustworthy, operating with absolute discretion.
• Must be able to lift/move materials, e.g. portable equipment, lead, gas cylinders, bottles of chemicals/waste containers
• Flexibility with scheduling requirements may include night shift, overtime, weekends and holiday coverage.

Work Environment

• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.
• Must be willing to work in a facility producing radioactive materials.  Note - employees are required to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Must be willing to wear a variety of Personal Protective Equipment (PPE), including eye and hearing protection, as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties. 
• Occasional kneeling, crouching, twisting the upper body, bending, stooping, pushing, pulling, or reaching may be required.
• Must possess good hand-eye coordination; close attention to detail is required.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.

Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

For information on Perspective Therapeutics, visit our website at: www.perspectivetherapeutics.com.