Quality Control Supervisor

Job Description

ONY Biotech Inc. is a small, privately held biopharmaceutical biotechnology company focused on the research, development, and commercialization of products for the hospital and acute care markets. Positioned for tremendous growth, this is a unique opportunity for the right candidate to be part of a great culture and take advantage of future career growth opportunities.

The ONY Biotech team is made up of professionals who are passionate and hopeful about the future of medicine. We believe in what we do, work as a team, and are persistent in pursuance of our goals, both for our ourselves and our team.

We support and encourage teamwork to accomplish our goals because the work we do here is so vitally important to the patients treated with our products. Above all else, we passionately embrace, support, and exhibit our core values of Passion, Persistence, Positivity and Professionalism.

When it comes to people we want to work with, we look for people who are:

Open. Honesty, respect, and clarity above all.

Results-Driven. Commit to goals and meet them, no excuses.

Changemakers. We embrace new and better ways to do work. Continuous improvement is our number 1 one goal.

Detailed-Oriented. Everyone at ONY Biotech performs their job thoroughly, accurately, and efficiently, always considering the potential impact on the business and our customers.

Collaborative. Work collaboratively with others, lead by example, and welcome diverse perspectives and experiences.

Position Overview:
We are currently seeking a Quality Control Supervisor to join our team and ensure that valid data is generated for the release of raw materials, in-process drug substance and finished drug product.

Job Title:Quality Control Supervisor

Responsibilities:

· Completes operational requirements by scheduling and assigning employees to perform daily duties, following up on work results.

· Assist in maintaining department results by counseling employees, monitoring work performance, and providing feedback to department Manager.

· Maintain process accuracy by performing periodic reviews of SOPs/related documentation and reviewing new/revised documentation when needed.

· Authoring, reviewing and/or authorizing all regulated documents (SOPs, Specifications, Quality Control (QC) Methods, Maintenance Procedures and Cleaning and Environmental Logs and Check sheets).

· Implement good laboratory practices and monitor operations and employees for compliance.

· Review of test data, control parameters and method worksheets for compliance to specifications.

· Performing in-process checks and veri­fication per SOPs.

· Preparing worksheet copies and filing completed worksheets, result printouts, tapes, etc.

· Manage the Stability Program.

· Orders supplies as needed to maintain inventory and traceability of reagents and supplies.

· Identify, document and investigate the root cause for and impact of problems occurring in the laboratory including Out-Of-Specification (OOS) results and deviations. Determine CAPA and implement plans.

· Review of Safety Data Sheets (SDS) and reporting of any changes.

· Validate methods including instruments to demonstrate they are fit for purpose and support the needs of the business.

· Monitor the performance, maintenance and validated state of methods and equipment.

· Initiate and support quality /safety /compliance/ productivity improvement/ risk mitigation initiatives.

· Assist with internal, external and FDA/other regulatory audits.

· Liaise with department leads to address audit deficiencies.

· Ensure accurate filing systems for GMP documents and electronic records.

· Maintain department staffing levels by recruiting, training new and incumbent employees, conducting periodic competency assessments and documenting these activities.

· Manage training programs and files, conducting audits as needed.

· Review quality outputs, change controls, and validation documents.

· Generate and manage Incident Reports, Change Controls, and CAPA reports.

· Prepare and ship samples to third-party testing laboratories. Manage results received and performance of laboratory.

· Maintains professional and technical knowledge by attending annual and continuous cGMP and safety training and undergoing periodic competency assessments.

· May be required to perform other duties as required/assigned.

Qualifications:

· Bachelor’s degree in medical technology, chemistry or science-related field is preferred.

. Quality Management experience 3+ years.

Relevant Experience and Competencies:

· Proactive self-starter with excellent communication and organizational skills.

· Ability to simplify complex problems, conduct root cause analysis, and provide clear recommendations.

· Practical experience with ISO17025 and Customer specific Quality System requirements

· Strong team-oriented leadership skills.

· Ability to work autonomously and collaboratively with a focus on results.

· In-depth knowledge of FDA regulations and other relevant guidelines.

· Strong understanding of quality systems, including Quality Control and quality assurance processes.

· Excellent project management skills with the ability to prioritize tasks and meet deadlines.

· Detail-oriented with strong analytical skills.

· Effective communication skills, both written and verbal.

Work Schedule:

• Tuesday - Friday (10 hour shifts)
• Full time

Compensation:

• $75,000-$85,000

Benefits:

• Paid Time off and paid holidays
• Health, dental, vision, life insurance
• Short and long term disability
• 401K
• EAP and wellness programs
• Paid lunch break
• All candidates are required to pass a pre-employment drug screen (excluding cannabis) and background verification.

In the subject line of your email, you must enter "Quality Control Supervisor".

Equal Opportunity Employer.

Job Type: Full-time

Pay: $75,000.00 - $85,000.00 per year

Schedule:

• 10 hour shift
• Day shift

Work setting:

• In-person

Work Location: In person