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:
Assists with coordinating quality activities of a designated Customer Focused Team to ensure that goals and objectives of the team are accomplished within prescribed time frames and in budget. Helps drive project success to provide PCI a competitive advantage in long-term quality customer management. Updates Batch Record Documentation and Material Specifications to ensure compliance standards are met and maintained. Facilitates customer questions for Batch Record review and Documentation Updates. Maintains a positive working relationship with internal and external customers.

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

1. Primary reviewer for master batch records, forms and specifications to ensure that the documents meet
internal and customer requirements for standards, procedures and requirements.
2. Assist with creating and updating batch records, forms and material specifications as well as organizing
internal and customer approval of batch records and specifications.
3. Assist with performing record reviews of completed orders and orders in process to ensure compliance with
cGMP’s and customer requirements. Assist as company liaison with customers concerning quality control
documentation. Help identify, communicate, track and resolve document related issues with other
departments and customers.
4. Performs finished product batch release of approved production lots.
5. Attend conference calls and customer meetings; provide complaint and quality related information.
6. Assist in the preparation of annual product review data.
7. Assist with generating and presenting quality related metrics and key performance indicators for team’s
performance.
8. Assist with the investigation of Quality deviations and the drafting of investigation reports associated with
such deviations.
9. Assist with addressing and documenting quality events with Production and Quality teams.
10. Assist with training, developing, and mentoring new Quality Coordinators.
11. This position may require overtime and/or weekend work.
12. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
13. Attendance to work is an essential function of this position
14. Performs other duties as assigned by Manager/Supervisor.
15. Develop, update and implement procedural changes throughout the organization.
16. Standardize documentation to ensure PCI’s Standard for Quality is achieved throughout our customer base.
17. Coach, train, mentor and develop PCI’s employees to ensure Quality Standards are met and maintained.
18. Schedule, host and lead meetings to develop, implement and / or update Batch Records, Material
Specifications, Forms, Work Practices and Standard Operating Procedures.
19. Assist with In-Process / Finished Goods Inspections, Annual Retain Inspections, Customer Complaint
Samples or Rework as needed to support the various groups throughout PCI.
20. Compile, update and analyze customer / internal data and metrics to identify potential trends and areas for
opportunities. Utilize the Microsoft Office Suite in detail to present data / facts in a professional fashion.
21. Assist and Support the RIT Investigation process through on-line interactions with the Operations staff.

Provide a summary of the findings / investigation to the appropriate Business Unit representative.
22. Present data to customers / internal management with ease and without undue hardship.
23. Maintain positive external and internal customer relationships with face-to-face, email and voice
communication. Provide the appropriate feedback within 24 hours of notification.
24. Assist with Supplier Investigations as needed.
25. Assess and provide detailed reports / summaries on the impact of process changes to PCI management

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

Stationary Position: From 1/2 to 3/4 of the day.
- 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: From 1/4 to 1/2 of the day.
On an average day, the individual can expect to move and/or transport up to 10 pounds
between 1/4 and 1/2 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 Requirement

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable 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 for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:
- Associate's Degree in a related field and/or 1-3 years related experience and/or training.
- College Level Mathematical Skills
- Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer 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 may be provided in various forms.

Preferred
- Ability to demonstrate attention to detail.
- Ability to work independently and/or part of a team.
- Ability to hold oneself in a professional manner.
- Ability to effectively present information to various people as the job requires.

The base salary hiring range for this position is ($51,120 - $57,500) 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, 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.