QA Specialist I - 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. The QA Specialist I - Doc Control will manage, coordinate, and maintain CGMP documentation, procedures, and records to ensure only controlled copies are reviewed, approved, issued, distributed, and archived. 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. . u2022 Maintain DCR/Quality system event databases and Master Documents / List u2022 Maintain Designated Satellite Areas for controlled paper based record management system u2022 Create Labels as needed u2022 Facilitate Client Batch Record Creation / Modifications / Approvals u2022 Issue and Archive Batch Records / Testing Data Capture Sheets / Lab Books / Equipment Log Books / Room Log Books/Quality system event documents u2022 Facilitate Biennial SOP reviews u2022 Maintain Document / Material / Batch Numbering Logs u2022 Obsolete Documents u2022 Writes and develops QA SOPs under minimal supervision u2022 Independently Develops/implements new systems for Document control under minimal supervision u2022 Manage Record / Document Filing system u2022 Proof and edit document changes including minor SOP updates, if necessary u2022 Assist with Line Clearances (Backup capacity) u2022 Assist in audit preparation and reconciliation u2022 Other duties as assigned 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. u2022 Requires the ability to communicate effectively using speech, vision, hearing and written word u2022 Requires bending, squatting, climbing, reaching u2022 Requires the ability to lift, carry, push or pull light weights (up to 20 pounds) 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. u2022 Interacts with all departmental staff, including giving training and/or presentations to large groups u2022 Work is completed in an office environment where the noise level is typically 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. u2022 Exceptional Organizational Skills u2022 Competent in MS Office u2022 Professional Verbal and Written Communication Skills Required u2022 Data Processing, Spreadsheets, SOP Generation u2022 Prior GMP experience preferably in a the pharmaceutical manufacturing industry u2022 High School Diploma/associates degree with a Minimum of ten years in a cGMP Environment; 5-10 year previous experience with Bacheloru2019s degree u2022 Detail Oriented u2022 Strong multitasker who is comfortable working in a fast paced u2022 Team oriented and strong collaborative approach to work #LI-LL1 Join us and be part of building the bridge between life changing therapies and patients. Letu2019s 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 companyu2019s 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 u2013 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._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we donu2019t say no, we figure out how.PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Created: 2025-11-26