Job Description
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.
The Associate Quality Account Manager I is responsible for assisting with coordinating quality activities for 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.
Essential Duties and Responsibilities:
- Creates, updates and peer reviews Master Packaging Instructions, forms, and material specifications to ensure that the documents meet internal and customer requirements, as well as obtaining internal and customer approvals of Master Packaging Instructions and specifications.
- Assist with performing batch record reviews of completed orders and orders in process to ensure compliance with cGMP's and customer requirements.
- Assist with creating and/or reviewing batch records to support the business. Primary Quality Assurance contact for assigned customer accounts.
- Assist as company liaison with customers concerning quality control documentation.
- Help identify, communicate, track, and resolve document related issues with other departments and customers.
- Attend or facilitate conference calls and customer meetings to provide or obtain quality related information and customer specific metrics.
- Assist with populating quality related metrics and key performance indicators for team's performance.
- Assist with initiating and investigating quality deviations with the responsible functional area.
- Initiating and completing supplier non-conformance reports and effectuates material control.
- 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.
Special Demands:
- Stationary Position: From 1/2 to 3/4 of the day.
- Move, Traverse: Up to 1/4 of the day.
- Operate, activate, use, prepare, inspect, or place: Up to 1/4 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): Up to 1/4 of the day.
- Communicate or exchange information: From 1/2 to 3/4 of the day.
- 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 less than 1/4 of the day.
Qualifications:
Required:
- Associate degree in a related field and/or 1-3 years related experience and/or training.
- Basic 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 identify and resolve problems in a timely manner.
- Ability to display a willingness to make decisions.
- Ability to display excellent time management skills.
- Ability to follow instructions and respond to management direction.
#LI-KH1
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.
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.
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