Lead, Clinical Quality Documen

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.

Performs all required regulatory functions of the Quality Document Coordinator including clinical document issuance, review, and retrieval in addition to having the responsibility for ensuring the overall timelines of activities within the group are met, the Mock Recall process is completed on time, and all special projects are completed as needed. Liaises with customers, internal departments (US and UK) and QP's. Create and maintain clinical documents in accordance with cGMP's. May perform inspection of individual shipments (cold chain and ambient) for clinical distribution.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Has overall responsibility for making decisions about jacket due dates and commitments.
• Responsible for ensuring all jackets are issued and reviewed/released by required due date.
• Runs the daily huddle meeting to coordinate daily activities of the Clinical QC Documents Coordinators, ensuring all timelines and commitments are met.
• Communicates to the applicable party, and management if necessary, if any commitments will not be met.
• Makes decisions on customer feedback/strategic decisions.
• Responsible for maintaining and collecting team Quality metrics.
• Present Executed Batch Record review status at the Daily Planning meeting.
• Responsible for the daily internal Batch Record Right First Time notification.
• Sign off on yield calculation and MAR's.
• Creates master files and enters approved label copy into EDMS system.
• Attends conference calls, CPT and other special project meetings for all assigned projects as needed.
• Conduct documentation training for new personnel added to the Clinical Quality and Operations team.
• Perform bi-annual documentation refresher training for all Line Leads and Quality Inspectors.
• Present key documentation tips and reminders on a quarterly basis to the Clinical Quality and Operations team.
• Client Audit participation as needed.
• Responsible for scheduling and performing bi-annual Mock Recalls.
• Company liaison with customers and internal departments concerning proper documentation technique, quality control and batch release to meet due dates.
• Company liaison with PCI UK Qualified Persons (QP's) and PCI US concerning quality control batch release and randomizations.
• Prepares and distributes required documentation for requested production work orders (including randomizations).
• Performs documentation review of completed orders to ensure compliance with cGMP's and customer requirements (includes WO, Receiving reports, retain photographs and randomization files).
• Prepares and submits executed Batch Records, accountability reports and necessary documentation to customers to facilitate product release.
• Helps direct employees to information books, records etc.
• Maintains and files released WO jackets.
• Helps identify, communicate, track, and resolve document related issues with other departments and customers. Helps identify, communicate, track, and resolve document related issues with other departments and customers.
• May develop, write, revise and review work practices and forms in accordance with PCI and GMP requirements. Verify changes adhere with SOP's, WP's and customer requirements.
• This position may require overtime and/or weekend work.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• Attendance to work is an essential function of this position
• Performs other duties as assigned by Manager/Supervisor.

QUALIFICATIONS:

Required:

• High School Diploma or GED and/or 1-3 years related experience and/or training.
• Basic Mathematical Skills
• Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations.

Preferred

• Ability to effectively present information to various people as the job requires.
• Ability to follow instructions and respond to management direction.
• Ability to identify and resolve problems in a timely manner.
• Ability to work independently and/or as part of a team.
• Ability to demonstrate attention to detail.

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, Diversity, Equity, and Inclusion (DEI) 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.