Quality Associate
Bora Pharmaceuticals Inc
Get more replies from employers
Send a job-specific resume in minutes.
Benefits offered by this job
Job summary
Bora Bora Pharmaceuticals is seeking a Quality Associate to support cGMP documentation, batch record review, and QA approvals in a regulated manufacturing environment. You will handle document lifecycle and assist with investigations under QA Management. Experience in FDA-regulated settings is required.
Preferred ASQ certification, strong attention to detail, and ability to work with operations to drive compliance and quality improvements.
Qualifications
- Interpersonal, auditing, and proofreading skills required.
- Attention to detail and ability to work independently or in a team.
Responsibilities
- Issues cGMP batch records and logbooks to operations.
- Review executed manufacturing and packaging batch records for accuracy.
- Perform document lifecycle administration and ensure compliance with procedures.
- Assist Operations and QA Management in investigations and resolutions.
Education
Tools
Job description
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.
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.
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.
Interpersonal, auditing, and proofreading skills required. Ability to work independently or with a team; ability to perform detailed work. Attention to detail required.
ASQ certification such as CQA, CQI, CQIA, etc. is a plus.
$52,000 - $67,000
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
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.
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
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.
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
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.
Bora Pharmaceuticals is focused on developing and manufacturing branded, generic and over the counter (OTC) healthcare and pharmaceutical products for patients around the globe.
At Bora Pharmaceuticals, we see it as our mission and our duty to make our mutual success more certain.
As an ambitious, future-focused company, we know better than most that our own success is shaped by our partners victories.
'/%3e%3cpath%20d='M101.744%2012.4726L102.894%2016.1947L99.0021%2013.2201L101.744%2012.4726ZM105.3%208.40937H100.488L99.0026%203.59473L97.5116%208.41047L92.7%208.40385L96.5965%2011.3834L95.1055%2016.1942L99.0021%2013.2196L101.408%2011.3834L105.3%208.40992V8.40937Z'%20fill='white'/%3e%3cdefs%3e%3clinearGradient%20id='paint0_linear_5593_1381'%20x1='90'%20y1='9.44471'%20x2='99'%20y2='9.44471'%20gradientUnits='userSpaceOnUse'%3e%3cstop%20stop-color='%2300AD70'/%3e%3cstop%20offset='0.998594'%20stop-color='%2300B67A'/%3e%3cstop%20offset='1'%20stop-color='%23DCDCE6'/%3e%3c/linearGradient%3e%3c/defs%3e%3c/svg%3e){kind=small}
