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Required! - Analytical Data Review Sp...
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Required! – Analytical Data Review Specialist (Pharmaceuticals)
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About the Job

PharmaCore (www.pharmacore.com) is seeking a highly motivated, energetic, results-oriented individual to join our team of dedicated professionals focused on customer service and quality. We are currently accepting resumes for the position of Analytical Data Review Specialist.

The GMP Analytical laboratory provides analytical services to both GMP and non-GMP manufacturing by supporting development and validation of analytical test methods, evaluation and testing of cleaning samples, raw materials, process intermediates, final APIs, and final dosage forms, characterizing/qualifying Reference Standards, and performing Stability evaluations to support the needs of our ever-growing list of clients. All activities are performed in accordance with specifications, standard operating procedures, approved test methods and/or protocols, and regulatory requirements.

The successful candidate will hold a minimum of Bachelor’s degree in Chemistry, Biology, Microbiology, or closely related discipline, and 4 years relevant pharmaceutical laboratory/analytical experience, including a minimum requirement of 1-2 years of data review experience.

This candidate will have a broad background, strong comprehension, and demonstrated skills in review of analytical and compliance oriented data and documentation. Strong attention to detail is a requirement. Thorough knowledge of SOPs, cGMPs, and Federal Regulations are a strong positive. Prior HPLC/GC/Other Instrumental experience is required. Certified Quality Auditor or similar is a strong plus. Hands-on experience in technical writing is a plus.

Key duties for this position include:

1)    Ensures the quality of laboratory data and reports. Efficiently and effectively reviews chromatographic/other data and related notebooks as specified by Standard Operating Procedures (SOPs). Evaluates data to ensure compliance with analytical methods, client criteria, and Good Manufacturing Practices (GMP).

2)    Must be able to understand and interpret analytical data (chromatographic and other). Scrutinizes and fully fathoms routine and non-routine testing/other data in order to ensure compliance, accuracy, and completeness of work as well as veracity of results based on documented data.

3)    Must be able to critically and in detailed fashion review/verify Reports, SOPs, Specifications, Analytical procedures, etc. Example: Reviews sample results tables and analytical reports for completeness and accurate representation of the data and report findings.

4)    Must be able to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.

5)    Must be able to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

6)    Organizes workflow and tasks to maximize efficiency (e.g., prioritize review/writing based on client/business needs, etc.).

7)    Demonstrated ability to work with others at all levels of the organization and have basic knowledge of computers and industry-related software.

8)    Ability to work effectively under pressure to meet deadlines

9)    Ensures compliance with company policies and SOPs as well as FDA and other applicable guidelines.

Other Experience/Skills: In-depth work experience in an analytical contract laboratory environment is a strong positive. Experience in stability study performance/evaluation is helpful. Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential. Proficiency with Microsoft software (Word / EXCEL / PowerPoint) is expected.

At PharmaCore, we recognize people as our most valuable asset. Our competitive salary and benefits package includes 401K, dental insurance, medical insurance, disability benefits, life insurance, a vision-care plan, paid sick time, casual dress, paid company holidays, free parking, and paid vacations.
*PharmaCore is an Equal Opportunity Employer. PharmaCore is committed to workforce diversity. M/F/D/V encouraged to apply. Drug-free work environment. No recruiters or agencies without a previously signed contract.

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