Copy of Quality Control Analyst

Description

BioFilm Inc is Hiring!!

Who We Are

BioFilm is a subsidiary of Combe Incorporated that specializes in manufacturing Astroglide Personal Lubricant and other sexual wellness products.

With state-of-the-art faculties and a commitment to excellence and continuous innovation, we leverage advanced technologies and stringent quality control processes to ensure our products meet the highest industry standards and regulatory requirements.

Why Work Here

As a privately held family business, we have a uniquely caring culture. But even with our family-feel, we’re all part of a high-performing team that loves to compete and win in the marketplace. To achieve that, we embrace a set of core attributes that guide our performance each day. We call these attributes C.A.R.E.

Collaborative. Accountable. Responsive. Entrepreneurial.

C.A.R.E. drives our success. We celebrate people for demonstrating C.A.R.E in their day-to-day work. We encourage our teams to give feedback to one another, so that we bring out the best in one another. We take a totally kind, totally honest approach to our communications with one another. We believe this makes for a more humane work environment where high-performers can thrive, work together effectively, and truly enjoy the work they do to drive our company forward.

• 4-day work weeks – every Friday off! 2 Shifts 6am-4:30pm or 7am-5:30pm
• Full health, dental, and vision insurance plus Health Reimbursement Account and Flexible Spending Account options available
• Matching 401K and profit-sharing
• Discretionary annual bonuses based on profits
• Generous PTO and holiday schedule including paid time off from Christmas Eve to New Year's Day
• Annual professional development opportunities

Our Quality Control Analyst, handles sampling, inspections, testing, and scheduling for a wide range of samples, including raw materials, in-process items, and finished good products. Ensures that all materials and final products meet specifications and manages the release of materials. Coordinate analytical tests with contract testing laboratories when required Gathers, organizes, and analyzes data for monitoring and trend analysis. Continuously investigates products and processes, implementing changes and modifications as directed by management. Assist with research, design transfer, and design control for new products. Provide operational support, lead risk analysis, problem-solving, and root cause analysis efforts. Administer the Company Calibration Program and other Quality programs as required. Oversee the qualification and full implementation of new lab instrumentation. Lead training on all QC testing equipment and procedures. Assign, coordinate, and supervise the daily activities and tasks of QC lab technicians and other personnel supporting the QC Lab. Promotes a culture of quality, continuous improvement, and outstanding customer service.

· Collects, prepares, schedules QC analytical testing for raw materials, bulk solutions, and finished goods while following all universal precaution, safety guidelines, while documenting test results.

· Performs microbiological, endotoxin, bioburden, and environmental monitoring testing.

· Prepare, maintain, and operate analytical instruments and equipment (e.g., ovens, viscometers, analytical balances, FTIR, osmometers, pH meters).

· Orders supplies, maintains inventory, & prepares chemical and bacteriological media, reagents, and test solutions used in the laboratory.

· Manage new lab equipment installation and implementation, including qualification/validation, generating operational and maintenance procedures/forms and training personnel.

· Leads or assists with root cause investigation for OOS, non-conformances, complaints, R&I or production investigations. Completes all investigational tasks on-time and in-full.

· Ensures proper follow up, closure and corrective actions based on inspection requirements and status.

· Represent and prepares the QC Lab/department during any regulatory or ISO audits.

· Perform inspections for incoming materials, including first article inspections (as required).

· Performs all necessary activities related with the inspection of these items.

· Ensure proper status labeling, real-time inventory transactions, and segregation of all material based on inspection/testing status.

· Lead or assist in establishing testing and specification parameters for inspection of chemicals and product.

· Assist with research, design transfer, and design control for new products.

· Monitor production lines to maintain high quality and consistency in finished products, and promptly escalate any errors or delays to the quality team. Support in-line escalations/investigations (as required).

· Initiate and assist in the root cause analysis required for out-of-specification (OOS) and Non-Conforming Material (NCMR) investigations with proper detail and accuracy for all materials/product that is not meeting specifications.

· Understand the Quality Systems as it relates to your job function.

· Manages the administration of the Calibration program.

· Assists in the Quality Systems administration to include but not limited to the NCMR, CAPA, and Customer Complaint systems.

· Responsible for gathering, organizing, and analyzing data for monitoring and trending. Assist with data-driven, sound decisions regarding product release on the manufacturing/mixing level or supplier escalations.

· Provides regular analysis and trend statistics reports to primary stakeholders.

· Ensures accuracy of product, bulk, environmental, water-related monitoring, and other (NCMR, CAPA, Deviation, etc.) databases for tracking and trending purposes.

· Operates, programs, and maintains computer software, forms, reporting systems, and documentation.

· Record and track test numbers related to production information.

Requirements

QUALIFICATIONS AND EDUCATION REQUIREMENTS:

• BACHELOR’S DEGREE IN BIOLOGY, CHEMISTRY, BIOTECH, OR OTHER SCIENCE RELATED FIELD IS REQUIRED.

• 1 YEARS QUALITY CONTROL/QUALITY ASSURANCE LAB EXPERIENCE; MICROBIOLOGY EXPERIENCE IS A PLUS.

• KNOWLEDGE OF CGMP/QSR, GLP AND FDA REQUIREMENTS.; MEDICAL DEVICE/ISO 13485 EXPERIENCE IS PREFERRED.

• NCMR, CAPA, STABILITY SYSTEM, AND CUSTOMER COMPLAINT INVESTIGATION EXPERIENCE PREFERRED.

• ASQ OR SIX SIGMA YELLOW/GREEN BELT CERTIFICATION IS A PREFERRED.

• AQL/STATISTICAL SAMPLING EXPERIENCE IS PREFERRED.

• FORMAL TRAINING/COURSE WORK IN STATISTICAL TECHNIQUES IS PREFERRED.

Salary : $70,000 - $75,000