RFD_Associate Quality Acct Mgr 2

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 inorder to ensure that the quality of PCI's products are in compliance with customer requirements as well as state andfederal regulations. Lead and play an integral part in individual project success and provide PCI a competitiveadvantage in long-term customer management.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform eachessential duty satisfactorily. The essential duties and responsibilities include the following but other duties may beassigned.

1. Accountable for overall management, reviewing, planning, and administering of resource allocation andworkload planning.
2. Responsible for direct supervision and personnel development including training and mentoring of directreports.
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 tointernal BU members and PCI Management.
7. Reviews and interprets customer standards, procedures and specifications for dissemination relative tobatch 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 tofacilitate product release.
10. Lead Quality improvement projects both within Quality departments and in cross-functional teamenvironments
11. Assist as company liaison with customers concerning quality control documentation.
12. Help identify, communicate, track and resolve document related issues with other departments andcustomers.
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.

Special Demands: The physical demands described here are representative of those that must be met by anemployee to successfully perform the essential functions of this job. The employee must be physically capable toperform the duties listed below with or without reasonable accommodations which may be made to enableindividuals with disabilities to perform the essential functions

- Stationary Position: 3/4 of the day and up.
- Move, Traverse: From 1/4 to 1/2 of the day.
- Operate, activate, use, prepare, inspect, or place: From 1/2 to 3/4 of the day.
- Install, place, adjust, apply, measure, use, or signal: None.
- Ascend/Descend or Work Atop: None.
- Position self (to) or Move (about or to): From 1/4 to 1/2 of the day.
- Communicate or exchange information: 3/4 of the day and up.
- Detect, distinguish, or determine: Up to 1/4 of the day.

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 work environment characteristics described here are representative of those an employeeencounters while performing the essential functions of this job. Reasonable accommodations may be made toenable individuals with disabilities to perform the essential functions.
The following are some environmental conditions that one may be exposed to on a daily basis and forvarious 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, moderate.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required forthe stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform theessential functions.
Required:
- Bachelor's Degree in a related field and/or 1-5 years related experience and/or training.
- College Level Mathematical Skills
- Advanced Computer Skills: Ability to perform the most complex computer tasks and operate variouscomputer programs.
- Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels
pertinent to professional needs.
- High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in
situations where there is only limited standardization. Ability to interpret a variety of instructions that maybe provided in various forms.

Preferred:
- Ability to effectively present information to various people as the job requires.

- Ability to identify and resolve problems in a timely manner.
- Ability to travel.

The hiring rate for this position is $62,960.00 - $71,000.00 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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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.