Associate Quality Account Mgr

Associate Quality Account Manager

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 :

• Primary reviewer for master batch records, forms and specifications to ensure that the documents meet internal and customer requirements for standards, procedures and requirements.
• Assist with creating and updating batch records, forms and material specifications as well as organizing internal and customer approval of batch records and specifications.
• 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.
• 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 key performance indicators for team's performance.
• Assist with the investigation of Quality deviations and the drafting of investigation reports associated with such deviations.
• Assist with addressing and documenting quality events with Production and Quality teams.
• Assist with training, developing, and mentoring new Quality Coordinators.
• This position may require overtime and / or weekend work.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• Attendance to work is an essential function of this position.
• Performs other duties as assigned by Manager / Supervisor.
• Develop, update and implement procedural changes throughout the organization.
• Standardize documentation to ensure PCI's Standard for Quality is achieved throughout our customer base.
• Coach, train, mentor and develop PCI's employees to ensure Quality Standards are met and maintained.
• Schedule, host and lead meetings to develop, implement and / or update Batch Records, Material Specifications, Forms, Work Practices and Standard Operating Procedures.
• Assist with In-Process / Finished Goods Inspections, Annual Retain Inspections, Customer Complaint Samples or Rework as needed to support the various groups throughout PCI.
• 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.
• 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.
• Present data to customers / internal management with ease and without undue hardship.
• Maintain positive external and internal customer relationships with face-to-face, email and voice communication. Provide the appropriate feedback within 24 hours of notification.
• Assist with Supplier Investigations as needed.
• Assess and provide detailed reports / summaries on the impact of process changes to PCI management.

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 :

Preferred :

The hiring rate for this position is $51,120.00 - $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), a flexible spending account, and a 401(k) plan.

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. PCI Pharma Services is an Equal Opportunity Employer / Vet / Disabled