Job Description
Job Description
Description:
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Under general direction, perform microbiology/EM testing and other activities in functions supporting the Quality Control department.
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Perform micro/EM testing in support of clinical release strategies.
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Perform all testing and activities compliantly following appropriate SOPs and procedures.
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Maintain controls and reference standards to support testing.
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Executes and follows SOPs, WPs, and quality policies.
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Peer review and archive analytical data in lab documentation systems.
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Support monthly/quarterly laboratory cleaning.
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Appropriate use of laboratory logbooks and monthly laboratory cleaning.
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Manage reagent/consumable inventory and equipment cleaning for assigned areas of responsibilities.
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Ensures cleanliness of laboratory working areas.
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Support and author OOS/OOE/OOT and deviation investigations.
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Participate in CAPA implementation in a timely manner.
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Follows GxP quality policies and procedures.
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Ensures all assigned training is completed within required time frame.
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Support 5S and Lean projects.
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Identify process improvements.
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Knowledge of LabWare, LIMS and/or other QC data systems.
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Knowledge of appropriate GMP/GLP quality systems (e.g., ESOPs, Trackwise, 1QEM, BMRAM, etc.).
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Support execution method qualification/optimization of methods.
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Interface with regulatory agencies during audits as required.
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In addition to these primary duties, provide coverage for all appropriate areas.
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Contributes to assigned projects by following predefined tasks and executing as instructed.
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Perform other job duties as assigned.
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Collects and generates data for trend reporting.
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Verify the accuracy of data generated.
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Contributes to the gowning qualification program by taking samples and analyzes and generates data.
Qualifications:
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BA/BS or MS or advanced degree in microbiology, biology, biochemistry, or other related science or equivalent work experience.
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Fluent in English.
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Experience/Professional requirement:
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1 - 3 years of relevant experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry.
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Knowledge of cGMP and an understanding of the concepts of GDP, good clinical practices and FDA guidelines, applicable state and foreign regulations, and standards routinely used in the industry (i.e., ANSI, ISO, etc.).
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Thorough knowledge of microbiological and environmental monitoring, test methods.
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Microbiology/Environmental Monitoring knowledge to facilitate investigations.
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Knowledge of LIMS systems.
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Ability to communicate clearly with a variety of individuals in various aspects of operations.
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Detail-oriented with expertise in problem solving and solid decision-making abilities.
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Strong interpersonal skills which include a professional demeanor when interacting with personnel.
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Strong written and verbal communication skills are essential.
Benefits:
Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Synectics is an equal opportunity employer.
Company DescriptionSynectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities
Company Description
Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities