Job description

GENERAL RESPONSIBILITIES:

This position is responsible and accountable for the technical review of analytical and microbiological testing of finished products, in-process samples, stability samples, raw material samples and environmental samples against cGMP compliance, approved methods and associated SOP’s, and method validations/verifications and/or compendial requirements. This position will be responsible for accurate reporting of all generated data.

MAJOR RESPONSIBILITIES:

· Perform in-depth technical review of all analytical and microbiological testing performed on finished products, in-process samples, stability samples, raw material samples, and environmental samples; ensuring compliance with cGMPs, approved methods and associated SOPs, and method validation requirements.

o Review audit trails for data integrity requirements.

o Provide technical support for laboratory investigations and review investigation reports for accuracy and completeness.

o Review incoming data and contract laboratory Certificates of Analysis, if applicable.

o Review chromatograms and integrations of chromatograms against method validations/verifications and/or compendial requirements for all chromatography methods.

o Review all raw data and test documentation and ensure data outputs (e.g. calculations) are correct and reported per the approved method.

o Provide Certificates of Analysis for test packets (finished product, raw material, special test requests, etc.).

· Responsible to assist laboratory management in the development of all levels of analysts in the laboratory.

o Participate in the qualification of analysts on specific analytical methods.

o Coach/mentor and assist in the technical development of analysts.

o Provide technical guidance to laboratory analysts on a daily basis.

· Provide laboratory information and documentation requests to site management and CM customers required for regulatory filings and product import/export needs, when required.

· Review product trends and identify out-of-trend results.

· Provide technical assistance in assessing method reliability and trend data for inclusion in PQR/APR.

· Provide technical assistance in the revisions or analytical methods, protocols, and associated SOPs.

· Participate in and adequately represent the laboratories in customer and regulatory audits of the facility.

· Participate in and lead projects for continuous improvements in methods or method execution.

· As a part of the employee’s job requirements, the employee may be required to handle wastes including hazardous wastes. The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing tests(s) administered by the company or consultant providing such training.

REQUIREMENTS:

• Position requires a Bachelor’s degree in chemistry or related field with a Master’s degree preferred.
• Five years or more of pharmaceutical industry experience and four years or more of Quality Control experience required.
• Extensive experience in chromatography methods (e.g. HPLC, UPLC, GC) and technologies required. In addition, experience with UV/VIS Spectrophotometry, FTIR Spectrophotometry, and other analytical techniques will be required.
• Extensive experience in chromatography integration software (e.g. Empower, ChemStation, Chromeleon, Totalchrom).
• Proven skills coaching/mentoring technical laboratory staff in a GMP/GLP laboratory environment.
• Method transfer and method validation experience desired.
• The position requires proven ability and skill in analyzing, understanding, and presenting technical data.
• Experience in technical wiring, communicating across organizational levels, and data analysis and trending is expected. Good interpersonal skills are a must.'

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Work Remotely

• No

Job Type: Full-time

Pay: Up to $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: One location

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