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Job Title: Label Designer
- Print labels for the packaging operation in compliance with cGMPs and PCI standard operating procedures.
- Activities include observing the label Kanban area, line clearance, label design, change control, monitoring
- Quality Inspections, reviewing work sheets and operational SOPs.
- Oversees daily schedule to assure on time deliverables of labels to production floor.
- Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
- Acts as the Quality oversight for Label Room operations
- Acts as a contact for customer account teams and the customer for the identification and interpretation of a customer’s labeling requirements.
- Works closely with customer account teams and other cross-functional areas ensuring accurate timelines and labeling requirements.
- At minimum, reviews and approves label room requests and associated forms for accuracy.
- Design labels in the Easy Label Manager.
- Create new serialization labels.
- Remains updated on Production team’s daily activities to ensure operation needs are met.
- Oversees the day-to-day activities within the department.
- Monitors the daily and weekly progress of projects managed by the department Supervisor communication, and weekly meetings.
- Reviews departmental standard operating procedures (SOPs) and facilitates training on SOP’s throughout the department.
- Participate in any CAPA resolution pertinent to Label Room processes and procedures.
- Oversee’ the Label Kanban area, documenting rejects and label usage
- Participates in customer visitations, audits.
- Monitors important departmental projects.
- Monitors activities for GMP compliance.
- Maintains housekeeping duties of the label room supplies to ensure supplies are always satisfied
- Mentors/trains label technician
- Any additional responsibilities as outlined by the Quality Ops Supervisor
SUPERVISORY RESPONSIBILITIES:
No Supervising of employees.
Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Must be physically capable to perform the above duties with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND/OR EXPERIENCE:
BACHELOR’S Degree in art related field or equivalent work experience
2-4 Years Label printing experience
2-4 Production floor experience
POSITION REQUIREMENTS:
- Knowledge and experience with cGMP and FDA regulations desirable
- Must be detail oriented and have the ability to handle multiple projects.
- Must have past label printing experience
- Possess above average verbal, written and interpersonal communications skills
- Possess above average documentation practices
- Computer literate with experience using spreadsheet and easy Label programs with label design
COMPUTER SKILLS:
Computer literate with experience using spreadsheets and Easy label programs with label design
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
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What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.