Junior Qa Engineer Jobs in Iowa (NOW HIRING)

ObjectiveThe Quality Assurance Engineer provides Quality oversight activities for the aseptic fill/finish manufacturing suite. Provide Quality Assurance technical expertise to ensure aseptic manufacturing facility, processes and support systems are in compliance with company guidelines and CGMP regulations, manufactured products and/or their raw materials, APIs, excipients or components.Essential Functions

• Collaborate with full range of personnel in manufacturing, facilities, inventory, quality control and assurance, supply chain, animal resources, and technical work teams that support Production to identify root cause of a problem and determine appropriate corrective action for investigations.
• Consult with a range of internal and external clients to correct non-routine and, or comprehensive issues, identify trends and determine corrective actions. Make recommendations that meet technical, regulatory and business requirements.
• Perform batch issuance, review and release of clinical drug products and associated records.
• Provide technical expertise in conducting investigations and make recommendations for targeted data and information collection as required for quality events. Contribute to data and information collection and statistical analysis.
• Alert management of critical issues that have significant impact related to manufacturing objectives and timelines.
• Develop, review and approve qualification/validation protocols and reports for facilities, utilities, equipment, processes and systems.
• Analyze qualification/validation data to ensure compliance with statistically sound, predefined acceptance criteria.
• Create and Update Quality Assurance and Quality Systems policies and Standard Operating Procedures (SOPs) to ensure compliance to CGMPs.
• Review validation reports, summarizing findings and providing recommendations for improvements.
• Conduct cross-functional risk assessments to identify potential quality and compliance issues.
• Implement and monitor risk mitigation strategies throughout the qualification/validation lifecycle.
• Ensure all qualification/validation activities comply with relevant regulatory standards.
• Maintain accurate and comprehensive documentation to support regulatory submissions and audits.
• Lead and approve change controls related to and represent Quality in Change Control Board meetings as needed.
• Represent QA in a range of team meetings, processes and initiatives both internally and externally.
• Provide quality oversight support for regulated operations, including review of documentation, compliance monitoring, and QA surveillance activities, as applicable.
• Actively promote safety rules and awareness. Demonstrate good safety practices at all times including the appropriate use of protective equipment. Report and take initiative to correct safety & environmental hazards.
• Handling of and/or exposure to potentially hazardous chemical, radiological and/or biological materials. Required to follow all safety procedures and use personal and protective equipment provided.
• Other duties as required.

Education/Experience

• BS/BA degree in a scientific discipline with 3-5+ years of progressive experience in the pharmaceutical or radiopharmaceutical industry or related GMP environment, or equivalent.
• 1-2+ years of experience in quality assurance and qualification/validation within a regulated industry (e.g., pharmaceuticals, medical devices, biotechnology).
• Aseptic fill-finish experience, including familiarity with qualification/validation of aseptic manufacturing technologies and facilities is required.
• Understanding of regulatory requirements and quality standards in the pharmaceutical industry preferred.
• Understanding of risk management, quality by design principles, statistical analysis (DOE, SPC, ANOVA, etc…)

Knowledge/Skill/Ability

• Ability to work in a team-oriented environment and represent the Quality organization on multi-disciplinary teams.
• Knowledge and experience with 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 Facilities, Utilities, and Equipment Qualification and 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 communication skills, both written and oral.
• High ethical standards, trustworthy, operating with absolute discretion.
• Highly organized with great attention to detail.
• Flexibility to work various shifts, as required.
• Ability to lift up to 50 pounds, to and from a mobile cart, utilizing proper lifting and movement techniques.
• Travel up to 10% may be required.

Work EnvironmentThe 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.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Will you now, or in the future, require sponsorship for employment visa status (e.g. H-1B visa status)?*

Are you willing to undergo a background check in accordance with local law?*

Were you referred to Perspective Therapeutics by a current employee? If yes, please provide their name below:*

The following questions are entirely optional. To comply with government Equal Employment Opportunity and/or…. We are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more .

Invitation for Job Applicants to Self-Identify as a U.S. Veteran

• A “disabled veteran” is one of the following:
  • a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or
  • a person who was discharged or released from active duty because of a service-connected disability.
• A “recently separated veteran” means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
• An “active duty wartime or campaign badge veteran” means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
• An “Armed forces service medal veteran” means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

I IDENTIFY AS ONE OR MORE OF THE CLASSIFICATIONS OF PROTECTED VETERAN LISTED ABOVE

I AM NOT A PROTECTED VETERAN

I DON’T WISH TO ANSWER

Voluntary Self-Identification of Disability

Voluntary Self-Identification of Disability Form CC-305
OMB Control Number 1250-0005
Expires 05/31/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualifiedpeople with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says wemust measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disabilityor have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one whomakes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If youwant to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract CompliancePrograms (OFCCP) website at www.dol.gov/ofccp .

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever hadsuch a condition, you are a person with a disability. Disabilities include, but are not limited to:

• Alcohol or other substance usedisorder (not currently usingdrugs illegally)
• Blind or low vision
• Cancer (past or present)
• Cardiovascular or heartdisease
• Celiac disease
• Cerebral palsy
• Deaf or serious difficultyhearing
• Diabetes
• Disfigurement, for example,disfigurement caused by burns,wounds, accidents, or congenitaldisorders
• Epilepsy or other seizure disorder
• Gastrointestinal disorders, for example,Crohn's Disease, irritable bowelsyndrome
• Mental health conditions, for example,depression, bipolar disorder, anxietydisorder, schizophrenia, PTSD
• Missing limbs or partially missing limbs
• Mobility impairment, benefiting from theuse of a wheelchair, scooter, walker,leg brace(s) and/or other supports
• Nervous system condition, for example,migraine headaches, Parkinson’sdisease, multiple sclerosis (MS)
• Neurodivergence, for example,attention-deficit/hyperactivity disorder(ADHD), autism spectrum disorder,dyslexia, dyspraxia, other learningdisabilities
• Partial or complete paralysis (anycause)
• Pulmonary or respiratory conditions, forexample, tuberculosis, asthma,emphysema

PLEASE CHECK ONE OF THE BOXES BELOW:

YES, I HAVE A DISABILITY, OR HAVE HAD ONE IN THE PAST NO, I DO NOT HAVE A DISABILITY AND HAVE NOT HAD ONE IN THE PAST I DO NOT WANT TO ANSWER

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.