Qc Inspect I Jobs

Reagent qualification and raw material testing.

Method development incorporating quality-by-design concept into development, qualification, and validation of bioassays per the FDA and ICH guidelines.

Experience sterile culture technique, cell preservation studies, and subsequent analytical assessment platforms for both drug substance and drug products.

Experience with client-facing tech transfer process and internal and external analyst training.

Knowledge of GMP, GxP, ICH, and 21 CFR part 11 regulations relevant to a clinical QC lab operation.

A bonus to have experience in molecular detection techniques.

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

1 – 3 years experience in medical device, pharmaceuticals, or other regulated product preferred

Working knowledge of standard laboratory practices and safety

Experience working in ISO Class 7 cleanrooms preferred

Experience with Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations

Bachelor’s degree in the biological or chemical sciences or equivalent

Medical Dental & Vision coverage (Available first day of employment)

Company supply PPE (Personal Protection Equipment)

Perform chemical, physical, and organoleptic analysis of raw products based on written procedures.

Perform daily verification of the equipment. Perform minor maintenance on test equipment as assigned.

Assure all retained samples are identified and properly stored.

Laboratory housekeeping based on Good Lab Practices.

o Assist with inventory management:

o Maintain all qualification and validation requirements for entering ISO classified area.

o Perform radiation safety duties according to SOFIE’s Corporate Radiation Compliance Program and site licensing requirements.

o Technical experience with computer-controlled automation preferred.

o Perform FDG and NaF synthesis according to SOFIE Standard Operating Procedures (SOPs):

o Ensure all materials/reagents are accepted according to SOPs and within expiry

Perform any other tasks/duties as assigned by management.

Knowledge and familiarity of equipment including HPLC/GC instrumentation, Atomic Absorption, UV/Vis and FT/IR Spectrophotometers.

Excellent organizational, interpersonal and communication skills (written and oral) required.

Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision.

Responsible for performing routine testing on raw materials and/or finished product pharmaceuticals in compliance with cGMPs.

Execute wet chemical and analytical methods to assess the purity, potency and stability of drug substances and finished products.

Utilizes knowledge of Nautilus, Analyst, and Dial M software for review of electronic data.

Experience with HPLC, GC, GC-MSD, or LC/MS instrumentation is helpful.

Reviews analytical data to ensure compliance with appropriate SOPs, GLPs, regulatory agency guidelines and client requirements.

Reviews data packets and forms for all study types.

Responds to QA inspection report findings related to QC review of data.

Enters QC dates into CMS.

0-2 years of relevant laboratory experience or experience in a cGMP/FDA regulated industry preferred.

Demonstrated knowledge in Microbiology and aseptic techniques required.

Detail-oriented with strong written and verbal communication skills.

Primary responsibility entails processing samples from the cleanrooms, including non-viable particulate, viable air and surface sampling, and personnel monitoring.

Performs growth promotion of raw materials.

Performs Gram stain and classic microbiology techniques.

Verifies and enters approved results in laboratory information management systems (LIMS).

Inform supervisor/manager upon observing OOS, OOL, or generation of deviations.

Communication— the individual speaks clearly and persuasively in positive or negative situations, demonstrates group presentation skills and conducts productive meetings.

Perform various microbiological testing procedures as per manufacturing/Quality Control batch records, stability protocols, raw material requests for testing, etc.

Perform environmental monitoring and utility testing of the facility.

Performs environmental monitoring during fill operations.

Record and review data in accordance with GxP to meet regulatory requirements and provide information relevant to product disposition.

No experience required with BS degree, Lab experience required with AA degree.

Lab experience desired with BS degree.

Knowledge of chemistry, statistics, computer-assisted data processing, and good manufacturing practices desirable.

1 year of lab experience required with BS degree, 3 years of lab experience required with AA degree.

Knowledge of chemistry, statistics, computer-assisted data processing, and good manufacturing practices is required.

Understand and exercise all safety requirements and procedures.

Some laboratory experience in a biological sciences laboratory is preferred.

Possess the ability to manage many tasks and in an organized fashion.

Review and maintain product compliance specifications, documentation control.

Gain proficiency on all testing areas.

Documentation of testing results and determination of aesthetic quality on finished product.

Completes other duties as assigned by Laboratory Management and/or Group Lead.

Demonstrates a working knowledge of the LIMS computer system. Enters data and

Laboratory experience is a plus.

Good practical knowledge of the laboratory environment.

Maintains accurate, complete, legible, and concurrent records of work performed and

Enters results in the laboratory notebook.

Acknowledge and process all quality documentation regarding production

Associates Degree, technical trade school or minimum 4 years industry technical experience

Chemical solvent testing experience preferred

Strong Customer Service Skills with the ability to follow up and follow through

Flexibility with scheduling and adapt to business requirements & needs

Follow and engage in the safety initiatives/programs & protocol at the site.

Knowledge of cGMP, Quality Systems, and ICH / regulatory guidance.

Alternatively, Master’s degree in above areas with 1 year of experience in a pharmaceutical/biotech QC laboratory or PhD in above areas.

Analytical testing to support product in-process, release, and stability programs.

Conduct, compile, and/or review Out of Specification lab investigations, deviations, and corrective and preventative actions plans.

Work with cross-functional teams to advance projects, maintain equipment, and authoring of documents and reports.

A commitment to Kashiv’s Vision, Mission, and Values is essential.

Perform simple identification of various chemicals or formulations as per methodology USP/NF and other test requirements

Basic understanding of the requirements of the USP and GMP requirements as applied to the testing of pharmaceuticals.

Performs routine maintenance activities in the laboratory and participates in the qualification and periodic calibration or verification of equipment.

Must have good communication skills.

Knowledge of Analytical techniques and able to incorporate them into daily tasks.

Good interpersonal skills that support working in a team environment.

Maintains all training requirements for assigned tasks

Adhere to QMS policy and regulatory requirements.

EHS Responsibilities – All Associates

Quality Responsibilities – All Associates

We are looking for professionals with these required skills to achieve our goals:

programs as part of the offering.

Required Skills, Knowledge, and Abilities

Effective interpersonal skills when working with others.

Ability to follow the specifics of the chart order.

Input data into computer programs.

Ability to operate, perform user maintenance, and troubleshoot high speed scanners.

Ability to pay attention to detail to ensure documents for the correct patient go in the chart.

Performs other responsibilities to support the needs of the department as assigned by Supervisor.

Minimum BS/BA in Chemistry, Biochemistry, or Bioscience with 0-2+ yrs Quality Assurance/Quality Control experience, preferably in the medical diagnostics industry.

Demonstrated ability and/or additional experience may be considered in lieu of a BS/BA degree.

Strong laboratory skills including pipetting, safety, and hazardous chemical handling.

High level of reading comprehension skills.

High level of verbal communication skills.

Utilizes personal skills and technical abilities to contribute to team and process performance as measured by team and process metrics.

Verify production lot tickets to customer requirements.

Interpret customer requirements for QC approval.

Earned a HS Diploma with 2-3 years of experience in a manufacturing quality product inspection environment.

Must possess intermediate to advanced computer skills

Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.

Participate in method qualification/validation activities, as necessary.

Analyze, document, and report experimental data in accordance with Resilience requirements.

4+ years of relevant experience

Basic understanding of cGMP requirements

Demonstrated knowledge / thorough understanding of microbiological methods and relevant regulatory guidelines

Strong planning and organizational skills

Assist management in evaluating and implementing new techniques and technologies with guidance.

At least 0-3 years of related experience or equivalent combination of education & experience.

Work with the reporting Manager to improve and develop outsource testing and stability program functional group.

Preferable, 1+ years’ experience in GxP setting

Experience working in and familiarity with cGMP Part 210, 211,11 and other relevant guidelines preferred

Knowledge of Quality control testing as it pertains to regulatory, compendial and ICH guidelines preferred