Aseptic Control Technician (Quality Control Laboratory Specialist) - 6 month renewable contract
Night Shift -- 6pm to 630am
12-hour shifts on a 2-2-3 rotation, meaning 2 days on, 2 days off, 3 days on, so on so forth.
Brief Job Description:
Autonomously performs tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site. The position requires operating equipment in various classified/non-classified areas up to a Class 100 aseptic environment and in a laboratory setting.
Ideal Candidate Profile:
-The HM is open to recent grads with a bachelors in a scientific related field.
-Other good fits would be candidates with 1-5 years of relative industry experience.
• Basic knowledge of sterile room techniques, chemical handling and usage
• Mechanical/technical aptitude
• Ability to work effectively in a team environment
• Candidate should possess the ability to work in a changing/demanding environment
• Prepare documentation of activities, actions, and results. Ensure proper documentation practices during job activities. Read SOPs (Standard Operating Procedures) and excerpts from technical documentation.
• Maintain accurate and complete records (for example: laboratory notebooks, quality records, sample receipts).
• Complete required training.
• Perform visual inspections.
• Use MODA to collect and analyze samples.
• Guide others on SOPs (Standard Operating Procedures), control documents, and/or other work instructions. Coordinate activities of support groups.
• Ensure that others carry out laboratory duties in a manner consistent with cGMP.
• Perform regular audits of SOPs (Standard Operating Procedures) and/or work instructions.
• Perform routine sampling activities and associated data entry.
• Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities.
• Read and interpret diagrams, drawings, and other schematics.
• Recommend and initiate activities to ensure area and equipment is maintained in a state of compliance.
• Provide 24/7 "on-call" support to others.
• Provide feedback on service and quality issues on a timely basis.
• High school graduate, vocational school graduate or equivalent
• Minimum two years of experience in a pharmaceutical production environment
• Must have the ability to effectively understand, read, write, communicate and follow
instructions in the English language
• Good attention to detail is required. Individual must be capable of keeping accurate
records and performing mathematical calculations.
• Working knowledge of MODA, Microsoft applications, SAP, KRONOS, and Trackwise
• Experience working in a LEAN manufacturing environment
• Knowledge of cGMPs and FDA policies/procedures
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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