QC Analyst II
QC Analyst II
Posted on :
20-05-2025
Employer Active
1 Vacancy
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Job Description
BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fillfinish services. From IND applications through commercial scale production we provide formulation and compounding fillfinish and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team s expertise to create a process design for our clients products that best 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.
Your Role
We are hiring an experienced QC Analyst II. The QC Analyst plays a vital role in ensuring the safety efficacy and consistency of our products responsible for rigorous analysis at every stage to ensure compliance with regulatory standards and internal quality guidelines.
- Quality Testing and Analysis: Perform routine and nonroutine analytical microbial chemical and physical testing of raw materials inprocess samples finished products and stability samples.
- Method Execution: Perform and document analytical methods tests and assays in strict accordance with SOPs ensuring compliance with GMP USP/EP/JP regulatory guidelines.
- Sample Preparation: Prepare samples and test solutions meticulously as per SOPs and international standards.
- Quality Investigations: Support investigations (OOS OOT deviations) and implement corrective and preventive actions (CAPAs).
- Equipment Handling: Set up operate and maintain laboratory equipment while ensuring its optimal performance.
- Safety and Monitoring: Follow stringent safety protocols including gowning and the use of personal protective equipment and support environmental monitoring activities.
- Data Integrity: Accurately document results while maintaining data integrity and identifying outofspecification test results for prompt reporting.
- Inventory Management: Verify inventory and expiry of reagents and standards and procure necessary consumables to ensure seamless lab operations.
- CrossFunctional Collaboration: Work closely with crossfunctional teams to support continuous improvement initiatives and enhance quality processes.
- Facility Cleanliness: Clean glassware and perform periodic cleaning of testing facilities to uphold hygiene and operational standards.
- Additional Responsibilities: Perform additional tasks as assigned ensuring adaptability and dedication to collective goals.
Requirements
- Bachelor s degree in Chemistry Biochemistry or related field.
- 35 years of experience in an analytical and/or quality control role within the pharmaceutical industry.
- Strong knowledge of QC analytical techniques test methods and procedures.
- Well versed in using analytical instrumentation.
- Experience in aseptic techniques and clean room environments.
- Advanced knowledge of regulatory requirements and compliance i.e. cGMP FDA and ICH guidelines.
- Strong analytical and problemsolving skills.
- Excellent communication and teamwork abilities.
- Ability to work independently and manage multiple tasks effectively.
- Detailoriented with a commitment to accuracy and quality.
Benefits
Offering a full suite of benefits BioTechnique is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance so you not only enjoy your work but also have the time and resources to live your life happy and healthy.
- Medical Dental and Vision PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs Basic Life Insurance Short/Long Term Disability and more.
- 401(k) and 401(k) matching
- PTO Sick Time and Paid Holidays
- Education Assistance
- Pet Insurance
- Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness 24Hour Fitness and more)
- Financial Perks and Discounts
Equal Opportunity Employment Statement
PSC 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.
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Bachelor s degree in Chemistry, Biochemistry, or related field. 3-5 years of experience in an analytical and/or quality control role within the pharmaceutical industry. Strong knowledge of QC analytical techniques, test methods, and procedures. Well versed in using analytical instrumentation. Experience in aseptic techniques and clean room environments. Advanced knowledge of regulatory requirements and compliance, i.e. cGMP, FDA, and ICH guidelines. Strong analytical and problem-solving skills. Excellent communication and teamwork abilities. Ability to work independently and manage multiple tasks effectively. Detail-oriented with a commitment to accuracy and quality.
Employment Type
Full Time
Key Skills
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