Clinical Label Control Coordin

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Direct point of contact for customers and vendors relating to clinical labeling to effectively communicate technical requirements for packaging purposes by understanding equipment functions, component designs, material structure, code and coding areas, and barcode data structures.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Demonstrate facilitation of various component label copy revisions and successful management of customer art and vendor print proof files by understanding different processes defined by customer and vendor requirements.
• Independent decisions to complete technical approval reviews including component drawings and vendor die lines, customer artwork, and vendor print proofs to ensure component design, barcode, and coding areas align with PCI packaging process as well as performing barcode scans and verifying barcode type, encoded data, density or cell size, and structure are accurate.
• Design labels to print internally (PCI Label Room); label copy and barcode data structures created per GS1 (Global Standards) and customer logistics, distribution center requirements that include standards for track and trace (serialization), HDMA (Healthcare Distribution Management Association), and HIBCC/UDI (Healthcare Industry Business Communications Council/Unique Device Identification).
• Direct point of contact to process internal drawings and vendor die lines through customer approvals.
• Proofreading accuracy and ability to multi-task in a fast-paced environment.
• Manage clinical randomization files including creation and comparison inspections.
• Schedule and host conference calls, meetings with customer and vendor representatives, as needed.
• Participate in Clinical trial operation planning meetings as required, interact with project manager, QC/QA, production, planning, validation and warehouse to ensure that jobs are completed in a timely manner minimizing delays to production.
• Assisting in the hosting of external and internal audits of the Labeling Department
• Complete component specification, LE form, and batch record reviews within SmartProd-Pilgrim.
• Conduct efficient and accurate departmental handover meetings prioritizing workload in line with production scheduling
• Assist in the training of others to use the label printing systems.
• Work in a safe manner at all times and highlight any safety issues to the appropriate person as soon as

• possible.

• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• This position may require overtime and/or weekend work.
• Attendance to work is an essential function of this position
• Performs other duties as assigned by Manager/Supervisor

QUALIFICATIONS:

• High School Diploma or GED and/or 3-5 years related experience and/or training.
• Basic Mathematical Skills
• Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.

Preferred

• Ability to effectively present information to various people as the job requires.
• Ability to display a willingness to make decisions.
• Ability to work independently and/or as part of a team.
• Ability to exhibit sound and accurate judgment.
• Ability to demonstrate attention to detail.
• Ability to identify and resolve problems in a timely manner.

The hiring rate for this position is $ 16.50 - 18.56 /hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).

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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.