Quality Control Specialist - Onsite

BioMagnetic Solutions is a highly innovative company bringing novel immunomagnetic cell selection technologies to the rapidly evolving cell and gene therapy fields. We are seeking a Quality Control Specialist to work in our facility in State College, Pennsylvania. The successful candidate will have a background in life sciences, such as biology, biochemistry, immunology, and/or bioengineering with a focus in quality assurance/quality control.

Summary

We are looking for a Quality Specialist that will assist in helping uphold our quality systems. This role will work within Quality Department and with other teams within the company. This person will gain experience in quality systems for standards including ISO 9001:2015 and ISO 13485:2016 in addition to GMP and GLP settings.

The company will offer extensive training to the successful candidate for this key role for the company.

Responsibilities:

Assist in the company’s overall compliance, by monitoring and maintaining control over key processes through the following:

• Work with interdepartmental teams on projects where quality assurance input is needed
• Be responsible for record maintenance
• Use data analysis tools and statistical techniques to drive data-driven decision-making
• Assist in creating company procedures and templates to maintain conformity within Quality Documentation
• Calibrate, verify, and maintain laboratory equipment and coordinate associated maintenance, repairs & qualifications
• Conduct inspections and measurements of raw material & components to verify adherence to specifications
• Lead or participate in continuous improvement initiatives
• Investigate and resolve product non-conformances, customer complaints, and other quality-related issues. Implement appropriate corrective and preventive actions to prevent recurrence.
• Support quality specific projects and implementations
• Other duties as necessary to support quality efforts and projects.
• Support in completing regular quality metrics/tasks
• Communicate statuses and completion of tasks to management

This individual will report directly to the Director of Quality.

The role is an onsite role, within our new facility within State College, Pennsylvania.

Qualifications:

• Able to read, understand and apply regulations
• Previous experience in a quality assurance role within IS09001 & ISO 13485 manufacturing environments preferred
• Able to manage a workload, prioritize tasks, and meet deadline
• Demonstrates critical thinking and a high attention to detail
• Exhibits a curiosity to learn
• Bachelor's degree in a scientific discipline or a related field
• Excellent communication skills, both verbal and written
• Able to manage time and resources effectively, prioritize tasks, and work well both independently and with others
• Knowledge of regulatory requirements, including FDA regulations and Good Manufacturing Practices (GMP) is preferred.

Benefits & Perks: In addition to competitive salary and PTO, BioMagnetic Solutions offers medical/dental/vision, 401k with company match and life and disability insurance.

WHO WE ARE:

BioMagnetic Solutions is proud to be an equal opportunity employer. Employment with our company is based solely on a person's merit and qualifications directly related to professional competence. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, family status, marital status, pregnancy, or related condition (including breastfeeding), sexual orientation, national origin, genetics, disability, age, or veteran status, or any other or any other basis protected by law.

BioMagnetic Solutions is also committed to providing reasonable accommodations to qualified individuals with disabilities in the employment application process. Additionally, BioMagnetic Solutions will also consider reasonable accommodations to enable qualified individuals with disabilities to perform essential job functions. To request an accommodation, please contact [email protected]; your contact information and let us know the nature of your request.

EEO/AA Statement

BioMagnetic Solutions is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits and training. BioMagnetic Solutions makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Accommodation Statement BioMagnetic Solutions is committed to the inclusion of all qualified individuals in the hiring process, including but not limited to those with disabilities. If you require reasonable accommodation(s) to participate in the application or interview process, please contact [email protected].

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