What are the responsibilities and job description for the Quality Compliance Analyst position at 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.
SUMMARY:
The Quality Analyst has the primary function to ensure compliance with regulatory requirements, with respect to the FDA, DEA, MHRA, EEU, and other regulatory agencies. The individual will also support regulatory submissions, inspections, and customer filing documentation requests. Participating and Host customer and regulatory inspections is also a requirement for this role. Attendance to work is essential function of this position.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Work directly with customers and global regulatory agencies related to regulatory submissions and customer filings
- Complete customer questionnaires related to the facility and systems
- Participate, Host regulatory and customer audits
- Participate during internal audits
- Coordinate audit responses
- Coordinates Regulatory Agency audits with customers and internal staff
- Compiling and presenting metrics in relation to their job performance and performance of the area of responsibility
- Write and implement procedures according to the current regulations
- Generating, reviewing and maintain internal and DEA documentation related to receipts, shipments and inventory
- Submission of information/reports to the DEA (i.e. Quarterly Reports, Annual Reports, Quota Requests)
- Performs other duties as assigned by Supervisor
EDUCATION AND/OR EXPERIENCE:
- High school education or at least five (5) years of pharmaceutical or pharmaceutical packaging experience.
- A college degree with a concentration in a scientific discipline is preferred.
- Possesses excellent organizational, time management and multi-tasking skills in order to meet commitments and deadlines.
- The candidate must be able to demonstrate basic proficiency with personal computers, business software (e.g., MS Office) and technical software (e.g., Master Control). Ability to create, use and interpret scientific tables, charts, and graphs.
- Prior experience in reviewing or preparing regulatory submissions is preferred. Experience with the requirements of handling Schedule I through V DEA controlled substances is also preferred.
- Any Lean Six Sigma or process improvement training is a plus
EQUAL OPPORTUNITY EMPLOYER/DISABLED/VETERANS
Join us and be part of building the bridge between life changing therapies and patients.
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.
LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company’s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.