Data & Documentation Specialist L1-Maternity cover

PCI Pharma Services; Tredegar; On-site; GBP 60,000 - 80,000; Full time

Job description

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.

Key Responsibilities:

• The job holder is required to work on their own initiative and largely independently on key responsibilities under the supervision of the Analytical Services Transfer and Data Manager.
• The job holder is responsible for generating high quality analytical specifications ensuring consistent deliveries for technical documentation for work that falls within the Analytical Services group.
• Assist in the analysis of data to help identify areas of improvement primarily within the department but also across the business where appropriate.
• To interpret analytical data and generate comprehensive gap analysis, review reports, analytical protocols and reports in line with regulatory requirements and business proposals.
• To perform laboratory data interpretation in support of ongoing data trending and maintain and review data trending records on a routine basis.
• To determine and champion best practice for the department in areas of data generation, documentation and review to maintain regulatory and industry best practice.
• To generate PQR data on a routine basis based on stability and release data generated within the department.
• To perform statistical analysis of analytical data to support deviation and OOS/OOT/OOE investigations.
• To track and trend team metrics, as required.
• To assist in the assessment of stability data for product shelf-life determination/extensions.
• To generate comprehensive analytical methods that are easily understood by analysts and technicians at all levels.
• To generate product and material specifications in line with customer and regulatory requirements.
• To update all above named documentation in line with PCI procedures.
• To ensure a consistent approach is taken to document writing and to ensure all protocols and reports are generated to a minimum of regulatory submission standard.
• To generate accurate cost proposals and change orders in line with service level agreements based on information supplied by the business development group.
• To review analytical and laboratory data within the department for accuracy, completeness and compliance with documented procedures.
• To communicate effectively with internal and external customers and participate with them in problem solving activities, as required.
• To assist in the analysis and presentation of departmental metrics data to aid in the selection of continuous improvement projects within the department and across the business where appropriate.
• To participate in identified continuous improvement projects within the department and across the business as required.

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.