QA Specialist II - Doc Control

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.

Job Summary

Maintain Quality System Master Documents and Master Document ListFacilitates workflows in the electronic document management system and legacy paper processes. Performs the creation, modification, and approval of Client Batch Records independently.Issues and reconciles batch records, testing data capture sheets, lab books, equipment log books, room log books, and Quality System event documents.Maintains Document, Material and Batch numbering logs.Writes and develops QA SOPs with minimal oversight.Administers the maintenance of the Record/Document filing system at designated sites.Proofs and edits document changes including minor SOP updates, as directed.Participate in or lead audit preparation and reconciliation. Support audit requests. Perform internal audit tasks.Supports metrics / report generation.Cross-trains and provides support for coverage of multiple production facilities as needed. Covers absences. Lead continuous improvement efforts and projects across the department, or multiple departments. Provide input, propose resolutions. Performs obsolete and administrative document workflow within Master Control. Leads Quality System Investigation and CAPA action itemsTrain others in doc control processes. Develops and implements new tools and processes for Document Control with minimal oversight. Participate in or facilitate functional area programs

Required

High School Diploma and a minimum of 10+ years of relevant quality assurance, manufacturing, or quality control experience in the Biotech, Pharmaceutical or Medical Device industries is required.Previous Document Control and/or eQMS configuration and system management experience required.Advanced knowledge of cGMPs, EU regulatory requirements, and FDA 21 CFR Parts 210,211 and 820 and Industry best practices required.Working knowledge of Computer System Validation and Change Control requirements.Lead large or cross-functional projects and improvement initiatives as assigned.Assist in developing project plans.Develop and meet timelinesIndividuals are expected to complete daily tasks and projects independently and in a team environment. Able to take direction and provide input for process improvements. Must also follow written instructions and learn from or mentor other team members. Superior professional communication skills across all levels of the organization written and verballySuperior customer service.Identify and lead large or cross-functional projects and improvement initiatives.May support more than one production facility.Expert skill level in MS Office, general computer uses and the electronic Quality Management System and associated tools. Excellent professional written and verbal skills. Team oriented.Excellent Organizational skills. Highly Efficient.Excellent attention to detail.Perform repetitive tasks with high level of detail, requiring decision making on daily tasks and improvement initiatives. Sound decision making ability required. Recommend solutions to Management for critical decisions.

Preferred

Ability to work independently and/or part of a team.Make updates to instructions and procedures, as directed to close gaps.Identify areas for improvement and collaborate with team to implement.Identify areas for improvement and collaborate with team to implement.

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.