QC Analyst II

BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, 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 multi-cultural 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 non-routine analytical, microbial, chemical, and physical testing of raw materials, in-process 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 out-of-specification test results for prompt reporting.

Inventory Management: Verify inventory and expiry of reagents and standards, and procure necessary consumables to ensure seamless lab operations.

Cross-Functional Collaboration: Work closely with cross-functional 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.

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.

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, 24-Hour 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 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.

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