What are the responsibilities and job description for the Associate Quality Acct Mgr 2 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.
Responsible for leading efforts in planning, directing, and coordinating customer focus team Quality activities in order to ensure that the quality of PCI’s products are in compliance with customer requirements as well as state and federal regulations. Lead and play an integral part in individual project success and provide PCI a competitive advantage in long-term customer management.
1. Accountable for overall management, reviewing, planning, and administering of resource allocation and
workload planning.
2. Responsible for direct supervision and personnel development including training and mentoring of direct
reports.
3. Customer contact for quality activities and management of customer expectations.
4. Attend conference calls and customer meetings; provide complaint and quality related information.
5. Prepares annual product review data as required for customers and routes for internal approval.
6. Generate and present quality related metrics and key performance indicators for team’s performance to
internal BU members and PCI Management.
7. Reviews and interprets customer standards, procedures and specifications for dissemination relative to
batch records, forms and material specifications.
8. Assist with organizing internal and customer approval of batch records and specs.
9. Performs and submits batch records, accountability reports and necessary documentation to customers to
facilitate product release.
10. Lead Quality improvement projects both within Quality departments and in cross-functional team
environments
11. Assist as company liaison with customers concerning quality control documentation.
12. Help identify, communicate, track and resolve document related issues with other departments and
customers.
13. Assist with addressing quality events with Production and QC teams.
14. Timely provision of reports and requested information to customers.
15. Function as the customer point for any comments or questions pertaining to defect events and
investigations.
16. Investigate and document investigation in formal report.
17. Enter, monitor, track, extend and close investigations and CAPA information in Pilgrim.
18. Meet with management to address issues or concerns with the deviations.
19. Review and approve internal and customer-based specifications for packaging components and processes.
20. Manage customer visits.
21. May include travel to meet with customers on projects and attend Business reviews.
22. This position may require overtime and/or weekend work.
23. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
24. Attendance to work is an essential function of this position.
workload planning.
2. Responsible for direct supervision and personnel development including training and mentoring of direct
reports.
3. Customer contact for quality activities and management of customer expectations.
4. Attend conference calls and customer meetings; provide complaint and quality related information.
5. Prepares annual product review data as required for customers and routes for internal approval.
6. Generate and present quality related metrics and key performance indicators for team’s performance to
internal BU members and PCI Management.
7. Reviews and interprets customer standards, procedures and specifications for dissemination relative to
batch records, forms and material specifications.
8. Assist with organizing internal and customer approval of batch records and specs.
9. Performs and submits batch records, accountability reports and necessary documentation to customers to
facilitate product release.
10. Lead Quality improvement projects both within Quality departments and in cross-functional team
environments
11. Assist as company liaison with customers concerning quality control documentation.
12. Help identify, communicate, track and resolve document related issues with other departments and
customers.
13. Assist with addressing quality events with Production and QC teams.
14. Timely provision of reports and requested information to customers.
15. Function as the customer point for any comments or questions pertaining to defect events and
investigations.
16. Investigate and document investigation in formal report.
17. Enter, monitor, track, extend and close investigations and CAPA information in Pilgrim.
18. Meet with management to address issues or concerns with the deviations.
19. Review and approve internal and customer-based specifications for packaging components and processes.
20. Manage customer visits.
21. May include travel to meet with customers on projects and attend Business reviews.
22. This position may require overtime and/or weekend work.
23. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
24. Attendance to work is an essential function of this position.
25. Performs finish product batch release of approved production lots
26. Performs other duties as assigned by Manager/Supervisor.
26. Performs other duties as assigned by Manager/Supervisor.
The hiring rate for this position is $69,920-$87,000 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.
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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.
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, Diversity, Equity, and Inclusion (DEI) 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.
Salary : $69,920 - $87,000
