Maxim Biomedical Inc Work Values

Daily Duties at Maxim Biomedical Inc:

Manage all phases of large-scale manufacturing and production projects including validation with internal and external partners. Spearheaded production of FDA-licensed diagnostic kit. Oversaw operations within Gel Electrophoresis Lab, Kit Assembly and Packaging, Cleanrooms, Buffer Preparation, and EIA Plate Production. Oversaw Large-Scale Cell Culture Production and Purification of HIV Viral Lysate and Recombinant Antigen in a BSL-3 facility. • Responsible for quality of product and product output. • Process problem solving and decision making. • Review completed production records and documents . • Writing/updating Master Batch Records/SOPs. • Liaising with Quality in respect of product/manufacturing issues • Assisting FDA 21 CFR 820 Compliance and ISO 13485 facility audits. • Active supervision of operators’ work and compliance with cGMP/Safety regulations; scheduling/assigning workload; Managing/planning manpower requirements; Conducting performance appraisals; Managing disciplinary action and grievance handling; Authorizing/scheduling annual and other leave, time off, overtime, etc. • Ensuring that training carried out is documented, tracked and evaluated. Assist in ensuring that current compliance issues and trends are critically evaluated and that training is provided where appropriate. Responsible for Validated processes and equipment, administered budgets for areas of responsibility. Participate in Continuous Quality Improvement Initiatives. • Perform deviation investigations and implement robust CAPAs to prevent reoccurrence. • Ensure New Product launches are prioritized and identify and remove potential road blocks to achieve launch target dates. • Keep team informed, engaged, customer focused and motivated by using daily team meetings and one to one interactions. • Use daily meetings to identify problems on the lines and escalate as necessary. • Conduct daily cross functional meetings to address all processing related issues. • Coordinate with all support groups to address and resolve all processing issues.

What they like about Maxim Biomedical Inc:

You highly value a work environment built on a formal structure, rules, and regulations. You do not enjoy the unpredictability of shifting priorities and deadlines that upset your routine. You require and enjoy direction, input and accountability as part of your work environment. You have a strong need to participate in making key decisions and feel left out if your superiors or co-workers do not seek your input when making decisions. You thrive on providing good customer service to both internal or external customers, and doing so makes you feel good.

Tags

cGMP, GMP, ISO13485, FDA 21 CFR

Skills

P&L responsibilities, Technology Solutions, Sales Support, Software Implementation, Requirements Analysis & Specification, Leadership

These are some of the questions we asked our climbers about their experiences with Maxim Biomedical Inc: