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.
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:
The Quality Assurance Coordinator is primarily responsible for performing executed batch record review, ensuring the documentation is accurate, complete and meets the god documentation principles of PCI Pharma Services. Ensures goals and objectives of the team are accomplished within prescribed timeframes and within budget. Helps drive project success to provide PCI a competitive advantage in long-term quality compliance and customer service.
Essential Duties and Responsibilities:
- Perform documentation and records review of completed orders to ensure compliance with CGMP’s and client requirements.
- Prepares and submits batch records, accountability reports and necessary documentation to clients to facilitate product release.
- Function as one of the client points of contact for comments or questions pertaining to batch documentation.
- Help identify, communicate, track and resolve document related issues with other departments and clients.
- Assist with providing quality related metrics.
- Meet with management to address issues or concerns with batch documentation.
- Reviews and interprets client standards, procedures and specifications for dissemination relative to batch records, forms and material specifications.
- Assist with routing, reviewing and approving controlled documentation as required.
- Assist with investigation / complaint writing and assessment as required.
- Organize and maintain NMR associated paperwork including samples and ensuring proper close out.
- Maintain accurate logs of all NMR’s. Perform NMR associated transactions within the ERP.
- Maintain required Quality Metrics related to NMR’s and report to Management on a routine basis.
- Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules
- This position may require overtime and/or weekend work. Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor.
Qualifications:
Required:
- High School Diploma or GED and/or 1-3 months related experience and/or training.
- Basic Mathematical Skills
- Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs.
- Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers.
- Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations.
Preferred:
- Ability to demonstrate attention to detail.
- Ability to follow instructions and respond to management direction.
- Ability to work independently and/or as part of a team.
- Ability to display excellent time management skills.
The hiring rate for this position is $21.69 - 24.41/hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
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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.
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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.
