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.
Summary of Objective:
Responsible to provide administrative, documentation and training support to the Quality Team, ensuring that documentation is in compliance with all applicable regulations, Good Manufacturing Practices (GMPs), Standard Operating Procedures (SOPs).
Essential Duties and Responsibilities:
1. Manage precise and accurate filing systems.
2. Document management for the department (i.e. SOPs, Certificates of Analysis (CofA's), Material Safety
Data Sheets (MSDS), protocol files, packaging documentation) and arrange for off-site storage if required and destruction.
3. Manages all employees' and temporary staff training records, identifying when retraining is required;
maintaining training database (ZQMS).
4. Change Control & Item Master Setup (IM) Management.
5. Logistics Protocol Management.
6. Deviations & Complaint Management.
7. CAPA Log Management.
8. Temperature Monitoring & Infitrak System Management.
9. Vendor/Supplier Qualification Management.
10. Provides assistance with audits - scheduling coordination, preparation of documentation, catering, etc. 11. Responsible for verification of material issuance to packaging operations.
12. Perform AQL inspections over packaged finished goods or incoming material, as required.
13. Verifies copy issuance of batch documents prior to execution.
14. Maintain QA Metrics spreadsheets.
15. Back up for QC incoming inspections.
16. Assists in packaging when requested.
17. Provides administrative support to the department as required.
18. This position may require overtime and/or weekend work.
19. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
20. Attendance to work is an essential function of this position.
21. Performs other duties as assigned by Manager/Supervisor.
Special Demands:
- Stationary Position: From 1/2 to 3/4 of the day.
- Move, Traverse: Up to 1/4 of the day.
- Operate, activate, use, prepare, inspect, or place: Up to 1/4 of the day.
- Install, place, adjust, apply, measure, use, or signal: Up to 1/4 of the day.
- Ascend/Descend or Work Atop: Up to 1/4 of the day.
- Position self (to) or Move (about or to): Up to 1/4 of the day.
- Communicate or exchange information: 3/4 of the day and up.
- Detect, distinguish, or determine: 3/4 of the day and up.
On an average day, the individual can expect to move and/or transport up to 10 pounds less than 1/4 of the day.
This position may have the following special vision requirements.
☒ Close Vision ☐ Distance Vision ☐ Color Vision ☐ Peripheral Vision ☐ Depth Perception ☒ Ability to focus ☐ No Special Vision Requirements
Work Environment:
The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.
➢ Work is primarily performed at a desk and/or in an office environment. for 3/4 of the day and up.
The noise level in the work environment is typically, quiet.
Qualifications:
Required:
- Post-secondary education in quality or equivalent
- Minimum of 2 years’ experience in quality control, preferable within the pharmaceutical or packaged
goods industry
- Excellent communication skills (oral and written), including technical writing
- Computer knowledge to use software programs such as Microsoft Office, proprietary software programs,
internet navigation, ERP etc.
- Excellent time, project management, attention to detail and negotiation skills
- Excellent interpersonal and organizational skills
- Ability to work with limited supervision
Preferred:
- Ability to display a willingness to make decisions.
- Ability to demonstrate attention to detail.
- Ability to hold oneself in a professional manner.
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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.
What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
