Quality Associate

Bora Pharmaceuticals

Maple Grove (MN)

Vor Ort

USD 52.000 - 67.000

Vollzeit

14 Tage+

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Benefits dieser Stelle

Health coverage

Retirement matching contributions

Paid time off

Professional development opportunities

Employee wellness programs

Employee Assistance Program

Zusammenfassung

Bora Pharmaceuticals is seeking a Quality Associate to support cGMP documentation, batch review, and final disposition in manufacturing and packaging operations. This role emphasizes rigorous documentation and adherence to quality procedures within FDA-regulated processes.

The position also involves investigations, document lifecycle administration, and collaboration with Operations to ensure compliance. ASQ CQI/CQA certification is a plus for the candidate pool.

Qualifikationen

High School diploma or equivalent with 3 years of FDA-regulated industry experience.
Associate degree (technical field) with 1 year of experience orBachelor's degree (technical field) with no experience accepted.
Experience in a cGMP production environment with documentation generation and review.
Experience in conducting and documenting investigations is a plus.

Aufgaben

Issues cGMP batch records and logbooks to operations and ensures documentation accuracy.
Review executed batch records with operations to resolve issues.
Perform final batch disposition.
Administer document lifecycle functions and adherence to procedures.
Assist in investigations and recommend documentation resolutions.
Participate in special projects assigned by QA Management.

Kenntnisse

Documentation

Auditing

Attention to detail

Communication skills

Independent work

Ausbildung

High School diploma

Associate degree in technical field

Bachelor's degree in technical field

Tools

ASQ certification (CQA)

Jobbeschreibung

About Bora

Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora's teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer's success more certain.

The Quality Associate issues cGMP documentation to operations in support of manufacturing and packaging operations. Reviews executed manufacturing/packaging documentation and dispositions batch release. Performs general quality assurance reviews/approvals. Performs document lifecycle administration functions.

ESSENTIAL FUNCTIONS

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Issues cGMP batch records and logbooks to operations in support of manufacturing and packaging operations. Ensures accuracy of documentation issued..
Perform review of executed manufacturing and packaging batch records to ensure documentation is complete and accurate. Works directly with operations personnel to resolve issues.
Performs final batch disposition.
Performs document lifecycle administration functions.
Ensures compliance and adherence to applicable department procedures. Provides suggestions for enhancements to procedures where necessary.
Assists Operations in situations requiring investigation. Provides suggestions for documentation resolution.
Participates in special projects assigned by QA Management.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

High School degree or equivalent and 3 years of experience in an FDA-regulated industry.
Alternatively, an associate degree in a technical field (e.g., Chemistry, Engineering, etc.) with 1 year of experience or a bachelor's degree in a technical field (e.g., Chemistry, Engineering, etc.) with no experience may be accepted.
Industry experience must be in a cGMP production environment (preferably Pharmaceutical or Medical Device) with demonstrated proficiency in documentation generation and review.
Experience in conducting and documenting investigations is a plus.

OTHER KNOWLEDGE, SKILLS & ABILITIES:

Interpersonal, auditing, and proofreading skills required.
Ability to work independently or with a team ability to perform detailed work.
Attention to detail required.

Certifications / Licenses

ASQ certification such as CQA, CQI, CQIA, etc. is a plus.

Compensation Range:

$52,000 - $67,000

Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience. Bora Pharmaceuticals offers a competitive total rewards and benefits package designed to support our employees' wellbeing, including: - Competitive salary and performance-based incentives - Comprehensive health coverage including medical, dental, and vision insurance - Retirement savings plans with employer contributions - Paid time off and flexible work arrangements - Professional development opportunities - Employee wellness programs and resources - Employee Assistance Program and Mental Health Resources Our Values At Bora, our values guide everything we do - from how we solve challenges to how we support our people.

We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone. These values drive innovation, strengthen our teams, and ensure that we provide the best services to our employees and clients. Bora Pharmaceuticals Injectables, Inc. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals Injectables, Inc. will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.

Compensation and Benefits

We offer a comprehensive benefits package designed to support our employees' wellbeing, including:

Competitive salary and performance-based incentives
Comprehensive health coverage including medical, dental, and vision insurance
Retirement savings plans with employer matching contributions
Paid time off
Professional development opportunities
Employee wellness programs and resources
Employee Assistance Program and Mental Health Resources

Core Values

At Bora, our values guide everything we do - from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.

Bora Pharmaceuticals is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.