Quality Assurance Packaging Line Inspector

Job Description

Business: Critical Care
Department: Quality Assurance
Location: Bethlehem Plant
Schedule: 7am-3:30pm

Job Overview
The purpose of this role is to provide a quality presence on the packaging line, perform start up inspections, line clearance and authorize start of runs and other packaging activities. To perform quality inspection on the line and assures appropriate disposition and destruction of printed components.

Key Stakeholders: Internal
Quality Assurance Team, Site Management, Packaging Team
Key Stakeholders: External
FDA or other health organizations
Reporting Structure
Directly reports to Quality Assurance Supervisor

Essential Duties And Responsibilities

1. 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 PCC procedures.
2. 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.
3. Maintain, complete, review and control packaging batch records to assure appropriate completion and handling of record.
4. Performance and accurate documentation of in process inspections and retain/customer samples.
5. Maintains appropriate control and labeling of finished goods materials leaving the packaging area (status of Finished Goods as Released, quarantined, etc.).
6. Assures appropriate usage, disposition and destruction of unused Packaging components, including cartons, labels and inserts.
7. Performs special projects and assignments as indicated by Quality Management.
8. Assist in maintenance and revision of procedures related to Quality Assurance activities on the packaging line.
9. To communicate any issues affecting the packaging line during line clearance, line setup and during inspections.
10. To provide oversight and assistance to the packaging team with any quality issues.
11. To communicate any issues affecting manufacturing and packaging, safety concerns, personnel concerns to the appropriate managers and work with them to resolve any issues.
12. To be an active Quality Assurance team member and work with the department on resolving all issues related to product quality.
13. Support overtime as needed.

Key Competencies

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

Education / Experience

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

General Oversight And Direction
Receives moderate to limited supervision working from objectives set by Manager. Employee organizes and carries out most assignments in accordance with standard practices, instructions or previous training. Employee handles some situations independently.

Equal Employment Opportunity
Piramal Critical Care is committed to Equal Employment Opportunity. It is the policy of the Company to encourage and support equal employment opportunity for all associates and applicants without regard to age, sex, race, color, ancestry, religious creed, national origin, pregnancy, physical or mental disability, medical condition, marital status, political affiliation, sexual orientation, disabled veteran or Vietnam Era Veteran Status.

Americans With Disabilities Act
Applicants as well as employees who are, or become, disabled must be able to perform the essential job functions either unaided or with reasonable accommodation. The organization shall determine reasonable accommodation on a case-by-case basis in accordance with applicable law.