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.

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• Maintain DCR/Quality system event databases and Master Documents / List

• Maintain Designated Satellite Areas for controlled paper based record management system

• Create Labels as needed

• Facilitate Client Batch Record Creation / Modifications / Approvals

• Issue and Archive Batch Records / Testing Data Capture Sheets / Lab Books / Equipment Log Books / Room Log Books/Quality system event documents

• Facilitate Biennial SOP reviews

• Maintain Document / Material / Batch Numbering Logs

• Obsolete Documents

• Writes and develops QA SOPs under minimal supervision

• Independently Develops/implements new systems for Document control under minimal supervision

• Manage Record / Document Filing system

• Proof and edit document changes including minor SOP updates, if necessary

• Assist with Line Clearances (Backup capacity)

• Assist in audit preparation and reconciliation

• 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.

• Requires the ability to communicate effectively using speech, vision, hearing and written word

• Requires bending, squatting, climbing, reaching

• 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.

• Interacts with all departmental staff, including giving training and/or presentations to large groups

• 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.

• Exceptional Organizational Skills

• Competent in MS Office

• Professional Verbal and Written Communication Skills Required

• Data Processing, Spreadsheets, SOP Generation

• Prior GMP experience preferably in a the pharmaceutical manufacturing industry

• High School Diploma/associates degree with a Minimum of ten years in a cGMP Environment; 5-10 year previous experience with Bachelor’s degree

• Detail Oriented

• Strong multitasker who is comfortable working in a fast paced

• Team oriented and strong collaborative approach to work

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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.