Associate Quality Account Mgr

PCI RFD Anderson Brecon dba PCI of IL; Illinois; On-site; USD 51,000 - 58,000; Full time

Benefits offered by this job

Health insurance

401(k)

Paid time off

Flexible spending account

Job summary

PCI Pharma Services in Rockford, IL seeks an Associate Quality Account Manager to coordinate quality activities for a Customer Focused Team and ensure timely, compliant documentation updates.

You will review batch records and material specifications, assist with customer inquiries, and maintain strong external and internal relationships to support PCI’s quality standards.

Qualifications

• 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.

Responsibilities

• Primary reviewer for master batch records, forms and specifications to ensure documents meet internal and customer requirements.
• Assist with creating and updating batch records, forms and material specifications and organizing approvals.
• Assist with performing record reviews of completed orders to ensure compliance with cGMPs and customer requirements; liaison with customers on quality control documentation.
• Performs finished product batch release of approved production lots.
• Attend conference calls and customer meetings; provide complaint and quality related information.
• Assist in the preparation of annual product review data.
• Assist with generating and presenting quality related metrics and KPIs for team performance.
• Assist with investigating Quality deviations and drafting investigation reports.

Skills

Math skills

Computer literacy

Professional communication

Analytical reasoning

Education

Associate's Degree

Tools

Microsoft Office

Job description

Position Title: Associate Quality Account Manager

Location: Linden Road, Rockford, IL 61109

Shift: 1st Shift

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.

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.

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 for various 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

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.

For Illinois residents: the hiring rate for this position is $51,120.00 to $57,510.00 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).

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.

Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real‑life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.