Quality Assurance Packaging Line Inspector

Germer International; Bethlehem (Northampton County); On-site; USD 65,000 - 90,000; Full time

Job summary

Germer International seeks aQuality Assurance professional to oversee packaging-line quality, ensure compliance with cGMP, and document batch records. You will issue BOMs, manage materials, and supervise line clearances with a focus on product integrity.

You will coordinate with cross-functional teams, apply strong communication skills, and contribute to continuous improvements in QA procedures and packaging processes.

Qualifications

• Minimum 2 years degree in science or technical field.
• 3+ years of experience in a related field.
• Strong understanding of pharmaceutical cGMP, industry standards and regulations.
• Strong verbal and written communication skills across functions and levels.
• Experience using SAP and TrackWise; proficient in MS Office tools.

Responsibilities

• Own overall product quality on the packaging line and document activities per procedures.
• Issue Master batch records and generate BOMs for packaging.
• Maintain and review packaging batch records and ensure proper handling.
• Perform in-process inspections and retain/customer samples.
• Control labeling and status of finished goods leaving packaging area.
• Support QA activities and revisions to procedures on the packaging line.
• Communicate packaging line issues during line clearance, setup, and inspections.
• Provide oversight and assistance to packaging team on quality issues.
• Escalate manufacturing/safety/personnel concerns to managers and resolve.
• Collaborate with QA to resolve product quality issues as needed.

Skills

Critical Thinking

Customer service

Verbal & written communication

Creative problem solving

Motivational disposition

Confidentiality

Coaching

Education

Science/Technical degree

3+ years experience

Tools

Microsoft Outlook

Excel

Word

SAP

TrackWise

Job description

Essential Duties and Responsibilities

• Responsible for the overall product quality on the packaging line, approval of line clearance and documenting all activities on the packaging line in accordance with procedures
• Issuance of Master batch records, generation of Bill of Materials (BOMs) for packaging and assurance that all material/components used in the packaging run are in accordance with the appropriate BOM
• Maintain, complete, review and control packaging batch records to assure appropriate completion and handling of records
• Performance and accurate documentation of in process inspections and retain/ customer samples
• Maintains appropriate control and labeling of finished goods materials leaving the packaging area (status of Finished Goods as Released, quarantined, etc.)
• Assures appropriate usage, disposition and destruction of unused Packaging components, including cartons, labels and inserts
• Performs special projects and assignments as indicated by Quality Management
• Assist in maintenance and revision of procedures related to Quality Assurance activities on the packaging line
• To communicate any issues affecting the packaging line during line clearance, line setup and during inspections
• To provide oversight and assistance to the packaging team with any quality issues
• To communicate any issues affecting manufacturing and packaging, safety concerns, personnel concerns to the appropriate managers and work with them to resolve any issues
• To be an active Quality Assurance team member and work with the department on resolving all issues related to product quality support overtime as needed

Key Competencies (knowledge, skills, and abilities every person must possess to be successful)

• Critical Thinking - using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems
• Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers
• Excellent verbal and written communication skills
• Creative and able to present various solutions
• Energetic, enthusiastic and motivational disposition
• Maintain confidentiality
• Coaching skills

Education/Experience

• Minimum of 2 years degree in science or technical field
• 3+ years of experience
• Strong understanding of pharmaceutical cGMP, industry standards, and regulations
• Strong verbal and written communication skills with the ability to interact across functions, departments, and seniority levels
• Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based systems including SAP and TrackWise
• Ability to explain problems, solutions and make recommendations
• Ability to handle various urgent requests in a professional manner
• Attention to details and organizational skills when handling all activities related to batch records