PCI Pharma Services
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.
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
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.
#J-18808-Ljbffr
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.
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
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.
#J-18808-Ljbffr