at PCI Pharma Services Ohio, LLC in Rockford, Illinois, United States
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.
Responsible for leading efforts in planning, directing, and coordinating customer focus team Quality activities in order to ensure that the quality of PCI's products are in compliance with customer requirements as well as state and federal regulations. Lead and play an integral part in individual project success and provide PCI a competitive advantage in long-term customer management.
Essential Duties & Responsibilities:
Accountable for overall management, reviewing, planning, and administering of resource allocation and workload planning.
Responsible for direct supervision and personnel development including training and mentoring of direct reports.
Customer contact for quality activities and management of customer expectations.
Attend conference calls and customer meetings; provide complaint and quality related information.
Prepares annual product review data as required for customers and routes for internal approval.
Generate and present quality related metrics and key performance indicators for team's performance to internal BU members and PCI Management.
Reviews and interprets customer standards, procedures and specifications for dissemination relative to batch records, forms and material specifications.
Assist with organizing internal and customer approval of batch records and specs.
Performs and submits batch records, accountability reports and necessary documentation to customers to facilitate product release.
Lead Quality improvement projects both within Quality departments and in cross-functional team environments
Assist as company liaison with customers concerning quality control documentation.
Help identify, communicate, track and resolve document related issues with other departments and customers.
Assist with addressing quality events with Production and QC teams.
Timely provision of reports and requested information to customers.
Function as the customer point for any comments or questions pertaining to defect events and investigations.
Investigate and document investigation in formal report.
Enter, monitor, track, extend and close investigations and CAPA information in Pilgrim.
Meet with management to address issues or concerns with the deviations.
Review and approve internal and customer-based specifications for packaging components and processes.
Manage customer visits.
May include travel to meet with customers on projects and attend Business reviews.
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 finish product batch release of approved production lots.
Performs other duties as assigned by Manager/Supervisor.
Qualifications:
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 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 effectively present information to various people as the job requires. Ability to identify and resolve problems in a timely manner.
Ability to travel.
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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,... For full info follow application link.
LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company’s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.
