- Execute packaging operations according to standard operating procedures (SOPs), ensuring compliance with cGMP (current Good Manufacturing Practices) and regulatory requirements.
- Report production and create labels in the ERP system (Syteline)
- Responsible for packaging and labeling finished goods in preparation for shipment to customers.
- Perform visual inspections of packaged products to verify accuracy, completeness, and adherence to quality standards
- Apply labels to packaging materials accurately and ensure all labeling information complies with regulatory requirements and product specifications
- Set up and operate packaging equipment such as filling machines, labeling machines, and sealing machines. Conduct regular equipment checks and maintenance tasks to ensure optimal performance.
- Complete packaging batch records, logbooks, and other documentation accurately and in a timely manner. Maintain thorough records of packaging activities for traceability and quality control purposes.
- Collaborate with the Quality Assurance department to investigate any packaging deviations or discrepancies. Implement corrective actions as necessary to prevent recurrence and ensure product quality
- Adhere to all safety protocols and procedures to maintain a safe working environment. Identify and report any safety hazards or concerns to the appropriate personnel
- Monitor packaging materials inventory levels and communicate any shortages or discrepancies to the relevant departments. Assist in the ordering and receiving of packaging materials as needed
- Work collaboratively with other members of the production team, including operators, supervisors, and quality control personnel, to achieve production goals and maintain efficient workflow
- Identify opportunities for process improvements in packaging operations and contribute ideas for enhancing efficiency, quality, and safety.
- Other duties as assigned
- High school diploma or equivalent; additional technical or vocational training in pharmaceutical manufacturing is preferred.
- Must be able to perform physical labor, capable of lifting up to 50 lbs.
- Previous experience in pharmaceutical packaging or a similar manufacturing environment is advantageous.
- Knowledge of cGMP regulations and quality standards applicable to pharmaceutical manufacturing.
- Familiarity with operating and troubleshooting packaging equipment and machinery.
- Strong attention to detail and ability to perform repetitive tasks with precision.
- Good communication skills and ability to work effectively in a team environment.
- Flexibility to work in shifts and overtime as needed.
- Commitment to maintaining a clean, organized, and compliant work area.
- Ability to lift and move heavy objects and stand for extended periods during the work shift.
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Packer - 3rd Shift - Twinsburg, United States - SaniSure LLC
Description
Job Description
Job DescriptionABOUT SANISURE
SaniSure is a multinational manufacturer of single-use bioprocessing solutions (SUT) used in the production of biological drugs, including monoclonal antibodies, cell therapies, gene therapies, and vaccines. With operations in the U.S. and in Europe, SaniSure operates a leading platform of vertically integrated critical fluid management technologies and integrated solutions. Its single-use products and system solutions are sold to global pharma and biotech companies and are used from R&D through full-scale commercial cGMP manufacturing of among the most innovative large molecule therapeutics and vaccines.
We continue to be on a robust growth trajectory, via both organic and inorganic growth, as the company capitalizes on increasing global demand and continues its transition from a component manufacturer to an integrated systems and solutions provider.
Our primary offering includes high-value assembly solutions and a portfolio of market-leading products, including PharmaTainer bottles and carboys and related assemblies, Mixed4Sure mixing solutions, Flex4Sure bags and bag assemblies, Fill4Sure needles and needle assemblies, fittings, clamps and a wide range of silicone, braided and thermoplastic tubing solutions. The company has a growing portfolio of innovative solutions serving fast-growth applications, such as cell and gene therapies.
SaniSure is a high-growth, nimble and innovative company with a strong customer and market focus. Join us and grow your career at SaniSure
Job Summary:
The Packer is responsible for ensuring the efficient packaging of products according to specified protocols and standards. Your primary duty will be to prepare and pack finished products for distribution while adhering to strict quality control measures and regulatory guidelines. Attention to detail, precision, and adherence to safety protocols are crucial in this role to maintain the integrity and quality of the pharmaceutical products. 3rd shift, 11:00 PM to 7:00 AM.
Duties and Responsibilities:
Qualifications
SaniSure is an Equal Employment Opportunity Employer.
SaniSure does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age, military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
