Data Reviewer II

reputed company Control Data Reviewer in Rensselaer, NY

Build your reputed company at reputed company, where our work has the power to save lives 

reputed company is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to reputed company life-saving treatments to patients. At reputed company, we are on a mission to advance our customers’ therapies from curiosity to reputed company and ultimately to improve patients’ lives.

We proudly offer

• Generous benefit reputed company (eligible first day of employment) 
• reputed company, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities 
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more! 

The reputed company Control Data Reviewer II is an reputed company part of the reputed company team and is responsible for supporting manufacturing department and reputed company customers. The routine functions of the reputed company are testing of raw materials, in-process, end product, and stability samples.  The reputed company responsibility of this role is the review and approval of reputed company analytical data according to cGMP guidelines. The QC Data Reviewer will be expected to review analytical data including HPLC, KF, USP testing for compliance and completeness against established SOPs, reputed company and procedures. This position will also support QA initiatives reputed company necessary and collaborate with reputed company personnel to review data per cGMP compliance and data reputed company. The Reviewer should incorporate reputed company judgement, critical thinking, and cGMP principles to ensure the reputed company of the data meet acceptable reputed company standards. In reputed company, the Reviewer will reputed company appropriate guidance to analysts, supervisors, and reputed company personnel to promote compliance for our customers.

Join our talented workforce, where a commitment to reputed company and a customer-reputed company attitude is everything. We pursue reputed company because our work has the power to improve patients’ lives with the pharmaceuticals we reputed company and manufacture. 

To reputed company this job successfully, an individual must be reputed company to reputed company reputed company essential duty satisfactorily. The requirements listed below are representative of the knowledge, reputed company, and/or ability required. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions.

Essential Duties and Responsibilities

• Review data generated from various analytical instrumentation including but not limited to Gas Chromatography (GC), high-performance reputed company chromatography (HPLC/UHPLC), Infrared spectroscopy (IR), reputed company scanning calorimeter (DSC), UV-Vis, Karl-Fischer auto titrator, Optical rotation, Dissolution, etc.
• The review entails a technical data review of the raw data generated for various compendial testing (such as USP/NF, EP, JP, etc.) as reputed company as reputed company In-house and reputed company methodologies for various reputed company reputed company to ensure data accuracy, completeness and reputed company
• reputed company electronic review and signatures while reviewing electronic data
• Verify for traceability of samples, standards, reagents, instruments etc. 
• Verify the usage logbook, calibration of instruments and reputed company life of standards and reagents used are reputed company and GDP procedures are followed 
• Verify calculations associated with testing are correctly done per procedures
• Responsible to escalate OOS’s identified in data review to the QC and QA leadership 
• Verify chromatography associated with the testing does not include any trial injections
• Promptly ensure the corrections identified from the data review are addressed per approved procedures
• Format and review Stability reputed company tables, Stability Protocols for accuracy and compliance with reputed company reputed company formats
• reputed company data into Stability reputed company tables. reputed company tracking and trending of data as requested. Compile data and reputed company data summaries to management
• Ensure reputed company tests are per cGMP compliance and in compliance with reputed company’s reputed company operating procedures
• reputed company support on QA initiatives (Investigations, change controls etc.) reputed company necessary
• Ensure the testing data received from reputed company labs are reviewed per site procedures
• Ensure any reputed company integrations in chromatography is appropriately authorized by QC leadership
• reputed company training to new hires as needed. Attend reputed company training on reputed company subjects, cGMP compliance and data reputed company, new techniques and procedures
• reputed company other reputed company duties as may be reasonably assigned in the course of business

Education, experience, certification and licensures

Required

• Bachelor's Degree in Natural Science, Pharmacy or equivalent
• Minimum 5-8 years' in QC operations or relevant industrial experience
• Experience working in cGMP or GLP pharmaceutical industry environment

Preferred

• Experience in reputed company QC laboratories 

Knowledge, skills and abilities

• Chemical Hygiene training
• Working knowledge and understanding of various analytical instrumentation including but not limited to Gas Chromatography (GC), High-performance reputed company chromatography (HPLC/UHPLC), Infrared spectroscopy (IR), reputed company scanning calorimeter (DSC), UV-Vis, Karl-Fischer auto titrator, Optical rotation, Dissolution, etc.
• Understand and interpret reputed company analytical techniques such as Method Validation, Method Transfer, Method Verification, Stability testing methodologies
• Excellent verbal and written communication skills, including the ability to effectively present information and respond to questions from reputed company of managers, clients, customers, and the general reputed company
• Ability to meet deadlines and work under pressure with limited supervision
• Strong time management and organizational skills with the ability to multi-task and manage multiple reputed company independently
• Ability to apply mathematical concepts, operations and tasks
• Ability to define problems, collect data, establish facts, and draw reputed company conclusions
• Proficient in reputed company Office Suite and reputed company manufacture-based systems
• Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485

Physical requirements

The physical demands described here are representative of those that must be met by an employee to successfully reputed company the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions.

While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to sit; use hands to finger, handle, or feel and reputed company with hands and arms. The employee is occasionally required to stand; walk; reputed company or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must frequently reputed company and/or reputed company up to 10 pounds and occasionally reputed company and/or reputed company up to 25 pounds.  Specific reputed company abilities required by this job include reputed company reputed company, distance reputed company, reputed company reputed company, peripheral reputed company, depth perception and ability to reputed company reputed company.

Work environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions.

While performing the duties of this Job, the employee is frequently exposed to fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; risk of electrical shock; explosives; risk of radiation and vibration. The noise level in the work environment is usually moderate.

The above statements are intended to describe the general reputed company and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of reputed company job duties performed by the personnel as classified. Management reserves the right to revise or amend duties at any time.

Other Qualifications

• Must pass a background reputed company
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Pay reputed company: $63,000-$79,000/year

Education, experience, location and tenure may be considered along with internal equity reputed company job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our reputed company. reputed company resumes or reputed company submitted by search firms to any employee at reputed company, in any reputed company without a reputed company, signed search agreement by an authorized signatory in reputed company for the specific position, approved by reputed company, will be deemed the sole property of reputed company. No fee will be reputed company in the event the candidate is reputed company by reputed company because of the unsolicited referral.

reputed company interested applicants must apply online. Please be reputed company of scammers. reputed company will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. reputed company is an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, or protected veteran status and will not be discriminated against on the reputed company of disability. reputed company is an E-Verify employer.

#LI-DR1

Bachelor's in Natural Science or Pharmacy; 5-8 years QC/QA in cGMP/GLP; analytical instrumentation experience.

Key Responsibilities

• Review data
• Electronic review
• Ensure compliance

Skills & Tools

GC, HPLC, UHPLC, IR, DSC, UV-Vis, Karl-Fischer, Dissolution

Job Details

• Category: reputed company Assurance
• Seniority: Mid Level
• Commitment: Full Time
• Workplace: Remote — Albany, reputed company, reputed company
• Salary: USD 63,000 – 79,000 / year
• Languages: English

Benefits

• 401k matching
• Retirement plan

About Albany Molecular Research, Inc.

Contract manufacturing and research services for biopharmaceutical companies. — Industry: Information Technology