Cleaning Specialist

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Job Title: Cleaning Specialist

Location: Assembly

Shift: 2nd Shift

Summary of Objective:

Dedicated and detail-oriented Cleaning Specialist to join our team. In this role, you will be responsible for ensuring the cleanliness and sterilization of our production equipment tooling; ensuring functionality of our machinery and adherence to the production schedule, which is crucial for maintaining optimal production efficiency. Your work will play a vital role in supporting our commitment to quality and safety standards.

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 are the following but other duties may be assigned.

Perform thorough cleaning and sanitization of all production equipment tooling, including the disassembly and reassembly of product contact and non-product contact parts as specified by cleaning protocols. Follow established cleaning procedures for all production equipment tooling to prevent cross-contamination and ensure compliance with hygiene standards. Follow established policies, procedures, and safety regulations without deviation. Follow strict safety guidelines, wearing appropriate Personal Protective Equipment (PPE). Safely and effectively use appropriate cleaning agents and chemicals, following specific mixing and usage guidelines. Mix and prepare cleaning solutions according to safety guidelines. Use and dispose of cleaning chemicals and other hazardous materials safely and responsibly, in accordance with safety data sheets (SDS). Visually inspect cleaned tooling/equipment to ensure the production equipment tooling is free of product debris or residue from previous production run prior to releasing. Inspect tooling/equipment to identify potential quality issues, damage, or areas needing attention or immediate repair. Wrap and secure tooling/equipment to maintain 60-day sanitization period while being transported and stored. Maintain accurate records of cleaning activities to support operational transparency. Maintain clean room sanitization through daily, weekly, monthly, and annual cleaning process routines. Monitor and replenishes clean room inventory and coordinates inventory order requests with the lead/supervisor. Ensure compliance with cGMP, corporate standards/PCI Quality System (PQS), site policies/procedures, regulatory requirements, and industry standards. Communicate regularly and effectively. Work cross functionally to ensure communication within the business is always up-to-date and utilizes all available channels. Effective communication skills to coordinate with team members and report issues to supervisors. Maintains attention to detail and quality while completing multiple or repetitive tasks and meeting product timelines. Partner with the PCI Validations department to prepare, execute, and close out validation documentation for tooling and process validation. Partner with Quality Systems to issue and reconcile PCI functional department logbooks. (Production, Maintenance, Quality). Perform documentation and records review of completed logbooks to ensure compliance with cGMP's and customer requirements. Ensure all documentation aligns with quality standards, regulatory requirements, and company policies. Strong understanding of quality assurance principles and regulatory practices is essential for this role. Use and effectively navigate PCI EDMS to obtain controlled documents and training relating to job role. Reads, understands and communicates information contained in controlled documents. Complete and attend required annual bloodborne pathogen training to stay informed about dangers and safe procedures. Responsible for the safe and thorough cleaning, disinfection, and removal of blood and other potentially infectious materials (OPIM) from a variety of settings. Participate in all required PAPR training sessions, medical evaluations, and fit testing to ensure competence and proper function of the equipment. Follow all required safety protocols, including wearing a PAPR in designated areas or during specific tasks that pose a respiratory hazard The skill to prioritize tasks and work efficiently to meet deadlines. The capacity to work effectively with minimal supervision. Attendance at work is an essential function of this position. This position may require overtime and/or weekend work. 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:

• Skills testing requirements met at approved grade level for position.
• Basic Mathematical Skills
• Familiarity with cleaning agents and safety protocols.
• 1-2 years of experience in Quality and/or providing support in a manufacturing environment.
• Strong attention to detail and ability to follow instructions accurately.
• Ability to adapt to changing priorities and work efficiently in a fast-paced setting.
• Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers.
• Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations.

Preferred:

• Ability to work independently and/or as part of a team.
• Proven experience in a manufacturing or industrial clean room.
• Proven experience in a quality role, preferably in a manufacturing or industrial environment.
• Ability to follow instructions and respond to management direction.
• Ability to display a willingness to make decisions.
• Ability to display excellent time management skills.
• Strong work ethic and commitment to maintaining a clean and safe work environment

The hiring rate for this position is $15.00 - $16.88/hour 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).

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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.