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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. Shift: 2nd Shift Summary of Objective: Determines and maintains quality standards developed in compliance with current Good Manufacturing Practices, the Company's own Standard Operating Procedures and customer requirements. Provides resolution to quality issues regarding components. Recommends solutions based on SOP / cGMP requirements. 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.
Coordinates the daily activities of IQA personnel. Responsible for overseeing quality improvement processes related to receiving inspection. Implements inspection criteria and testing Study and standardize departmental work practices to improve quality and efficiencies of subordinates. Helps resolve quality related issues with other departments and customers. Motivates, develops and provides continuous training either through the use of departmental work instructions, examination of cGMP's and SOP's, specific customer requirements or by personal instruction. Prepare periodic and special reports concerning departmental activities, problems, quality systems, schedules, etc. Reviews daily paperwork to assure all customer requirements and quality standards have been met and maintained. Promotes continuity of shifts through cooperation and communication within as well as with other departments. Assist in the performance of monthly internal audits and any necessary corrective action to follow-up Trouble-shoot special equipment and software utilized during incoming inspections, i.e. barcode scanners, auto comparators, tridium displays. May disposition NMR's. Recommend and participate in disciplinary activities of subordinates. Maintain testing equipment and supplies needed for the department May assist in performing investigations, may write reports, memos, or letters. Responsible for technical review of all business critical NMRs and work with Procurement and supplier to resolve issues. 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.
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:
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. High Standard of Report Writing
Preferred:
Ability to effectively present information to various people as the job requires. Ability to work independently and/or part of a team. Ability to display a willingness to make decisions. Ability to display excellent time management skills.
#LI-MC1 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, 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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PCI Pharma Services
Nov 08, 2024