QA Associate
QA Associate
Posted on :
23-03-2024
Employer Active
1 Vacancy
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Jobs by Experience
3-5years
Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
23-03-2024
Job Description
The work we do at BioTechnique has never been more important and we are looking for talented candidates to join us. We re growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in people s lives. Join BioTechnique and help create the next vaccine cure or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here you ll work alongside and learn from some of the most dedicated scientists engineers and manufacturers in the industry. We re proud to cultivate a culture that will fuel your passion energy and drive. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At BioTechnique you determine what s possible.
BioTechnique is a highly potent sterile injectable and clinical oncolytics manufacturing company dedicated to providing cytotoxic and high potency sterile injectable fillfinish services. BioTechnique s project management and client services staff work closely with our clients to meet all manufacturing needs. From IND applications through commercial scale production we provide formulation and compounding fillfinish and optional lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team s expertise to work with our clients to create a process design for their product that suits their needs.
The Experience
With operations spanning the globe and featuring a multicultural team BioTechnique is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team you will be offered the ability to feel inspired in your career explore your professional passions and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such you will not only be offered a compensation and benefits structure that rewards you but also be provided with the tools that will help you grow and learn.
At BioTechnique it s about more than just a job it s about your career and your future.
Your Role
The Quality Assurance Associate plays a critical role in ensuring compliance with all quality standards and guidelines. The QA Associate will analyze systems and procedures identify any potential issues and work with the Quality Team to ensure process improvement and resolutions. Candidates should have a strong background in the pharmaceutical industry and operations with experience in sterile manufacturing.
- Identify and implement process improvements in our ACE QMS system and workflows and/or procedural events.
- Maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
- Support and execute software validation protocols. Assist in the development of quality systems and metrology systems as needed.
- Review author and develop required documentation including standard operating procedures test methods raw material specification protocols and related control documents. Ensure instructions are clear and are consistent with quality objectives.
- Perform independent technical review of documentation during and postexecution of cGMP activities. Document review includes but is not limited to batch records calibration records QC data enviornmental data and maintenance records.
- Write and execute deviations CAPA and conduct effectiveness checks.
- Follow safety initiates and assist upper management with the compliance of SOPs and specifications
- Ensure all specifications are met and that applicable requirements are completed and acceptable.
- Analyze and report data/findings to appropriate departments.
- Collaborate with crossfunctional teams/departments to investigate and review any potential risks or issues. Implement effective mitigation strategies.
- Assist in preparing for inspections by regulatory committiees or customers.
- Particpate in audits remotely.
- Additional responsbilities as required.
crm.templates.job.description.requirements
- Must be able to support 8am 5pm US EST time zone.
- Must be able to travel for 1 month duration twice a year.
- 35 years of direct experience in a Quality Assurance role within the pharmaceutical manufacturing/sterile manufacturing environment.
- Strong knowledge of pharmaceutical operations.
- Aseptic experience is preferred.
- Strong knowledge and understanding of QA principles concepts industry practices and standards.
- Proficient in writing reviewing and investigating quality events.
- Experienced leading internal projects or initiatives. Ability to serve as a resource for team memebers.
- Experienced with electronic systems and QMS systems such as Veeva SAP LIMS TrackWise etc.
- Strong knowledge of EU and US markets standards and regulations.
- Proven success in reviewing and supporting quality documentation such as batch records calibration/maintenance records quality data and so on.
- Strong technical writing skills with proven success in writing deviations CAPA etc.
- Detailoriented and able to demonstrate a high standard of integrity.
- Excellent time managment and organizational skills.
- Strong independent judgement and decision making capabilities.
- Excellent interpersonal and communication skills (both verbal and written).
- Proven success working collaboratively on a global team.
Equal Opportunity Employment Statement:
BioTechnique is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees interns and applicants for employment. Consistent with this commitment our policy is to comply with all applicable federal state and local laws concerning employment discrimination. Accordingly the Company prohibits discrimination against qualified employees interns and applicants in all aspects of employment including but not limited to: recruitment interviewing hiring (or failure or refusal to hire) evaluation compensation promotion job assignment transfer demotion training leaves of absence layoff benefits use of facilities working conditions termination and employersponsored activities and programs including wellness social and recreational programs. Employment decisions will be made without regard to an applicant s employee s or intern s actual or perceived: race color religion sex (including pregnancy gender identity and sexual orientation) national origin age (40 or older) disability genetic information or any other status protected by law.
#LIFF1
Must be able to support 8am - 5pm US EST time zone. Must be able to travel for 1 month duration, twice a year. 3-5 years of direct experience in a Quality Assurance role within the pharmaceutical manufacturing/sterile manufacturing environment. Strong knowledge of pharmaceutical operations. Aseptic experience is preferred. Strong knowledge and understanding of QA principles, concepts, industry practices, and standards. Proficient in writing, reviewing, and investigating quality events. Experienced leading internal projects or initiatives. Ability to serve as a resource for team memebers. Experienced with electronic systems and QMS systems, such as Veeva, SAP, LIMS, TrackWise, etc. Strong knowledge of EU and US markets, standards, and regulations. Proven success in reviewing and supporting quality documentation such as batch records, calibration/maintenance records, quality data, and so on. Strong technical writing skills with proven success in writing deviations, CAPA, etc. Detail-oriented and able to demonstrate a high standard of integrity. Excellent time managment and organizational skills. Strong independent judgement and decision making capabilities. Excellent interpersonal and communication skills (both verbal and written). Proven success working collaboratively on a global team. Equal Opportunity Employment Statement: BioTechnique is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant s, employee s, or intern s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law. #LI-FF1
Employment Type
Full Time
Key Skills
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