QA Floor Supervisor 1st Shift

KVK Tech; Newtown Township (Bucks County); On-site; USD 60,000 - 85,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Floor Supervisor to enhance its Quality Assurance operations. This role involves monitoring day-to-day activities of QA inspectors, ensuring compliance with industry standards, and managing training for staff. Ideal candidates will possess a Bachelor's degree in Chemistry and demonstrate strong leadership abilities. Join a dedicated team focused on continuous improvement and compliance with FDA guidelines.

Qualifications

• Preferred education is a Bachelor's degree in Chemistry.
• Requires strong leadership and organizational skills.
• Knowledge of 21 CFR 210 and 211 regulations essential.

Responsibilities

• Monitor and assign daily activities to QA inspectors.
• Review and verify GMP logbooks and perform in-process checks.
• Train employees on compliance and documentation.

Skills

Leadership

Organizational Skills

Project Management

Attention to Detail

Education

BS in Chemistry

Job description

Job Description

Job Description

Department: Quality Assurance

Job Title: Floor Supervisor

FLSA Status: Exempt

Reports To: Assistant Manager

1. Role Purpose:

The Quality Assurance Assistant Manager ensures that products manufactured by their employers meet industry and federal standards, and aims to make the entire manufacturing process more efficient.

2. Key Duties & Responsibilities:

• Monitoring and assigning day-to-day activities to QA inspectors.
• Carrying out line clearance activities in Manufacturing/Packaging during batch-to-batch and product-to-product changeovers for various dosage forms (e.g., Tablets, Capsules, liquids, powders).
• Sampling and releasing Raw Materials, Packaging, and Labeling Components.
• Reviewing primary manufacturing documents such as Master Manufacturing Records, Master Packaging Records, and Process Validation/Cleaning Validation protocols.
• Performing in-process checks during compression, encapsulation, coating, and packaging.
• Online review of Batch Production and Packaging records.
• Reviewing and verifying GMP logbooks (equipment, room, DEA activities, etc.).
• Collecting and submitting in-process and finished product samples to Quality Control. Final product release to the market.
• Verifying that Quality Control testing, OOS investigations, validations, and related activities are completed before drug product release.
• Preparing and reviewing SOPs and protocols.
• Issuing Batch Records and archiving all related documents.
• Supporting deviation closeouts, writing investigation reports, and following up on hold notices and CAPAs.
• Supporting customer complaint investigations and trending activities.
• Participating in Return Drug Product program.
• Training employees on documentation, cGMP, and SOPs; reporting errors and re-training/disciplines as needed.
• Supporting annual quality review activities.
• Ensuring compliance with FDA guidelines and company data integrity policies.
• Performing other duties as assigned.

3. Typical Supervisory Responsibilities:

Serves as an effective member of the Quality team, mentoring other Quality employees. Ensures adherence to procedures and identifies areas for improvement through training and system updates.

4. Education & Experience:

Education: BS in Chemistry preferred.

5. Technical Competencies/Certifications/Licenses:

• Ability to work with urgency, prioritize, and meet deadlines with strong organizational skills.
• Demonstrated leadership, initiative, and ability to lead by example.
• Flexibility to adjust work schedules based on business needs.
• Strong project management skills, ability to work independently and in teams.
• Knowledge of 21 CFR 210 and 211 regulations.
• Documentation skills in line with cGMP, USFDA, and 21 CFR guidelines.
• Adherence to cGMP, OSHA, EPA, and DEA regulations.
• Attention to detail, organizational and communication skills.

6. Physical Demands & Work Environment:

Requires walking, sitting, handling tools, reaching, balancing, stooping, crouching, bending, talking, and hearing. Must lift/move up to 20 pounds. Vision abilities include close, distance, color, peripheral, and depth perception.