Analytical QA Supervisor

Purpose:

This position requires a strong analytical chemistry/lab background and experience. The job duties for this position include but are not limited to the following:

Scope:

The Quality Assurance (QA) supervisor position is an individual contributor role and reports to the Head Quality Assurance Analytical company located at Fall River, MA.

The job duties for this position include but are not limited to the following:

Confirming and ensuring the compliance of the protocols and reports of method validations / verifications / comparison reports and any other study reports.

Monitoring and ensuring of current Good Laboratory Practices (cGLP) followed by laboratory personnel during routine operation to ensure adherence to procedure.

Verifying the standard operating procedures (SOPs) and test procedures.

Verifying process validation and characterization-related documents.

Coordinating with the Regulatory Affairs (RA) and Analytical Laboratory Teams to arrange required documents for timely submission as part of new and existing abbreviated new drug applications (ANDAs).

Maintaining all the incoming documents with proper tracking, recording, storage and archival of the documents.

Ensuring review, compliance and approval of laboratory raw data which includes audit trials.

Reviewing and identifying the gaps within the system during routine monitoring and informing the supervisor for necessary improvements in the identified areas.

Actively participating in laboratory investigations and incidents as well as ensuring the proper compliance.

Evaluating and confirming the compliance related to raw materials, in process and finished product analytical documents.

Conducting random internal audits in analytical lab and ensuring the compliance.

Assessing and implementing of Pharmacopoeia changes whenever any new edition, supplement, amendment, or other changes of any Pharmacopoeia are in effect.

Performing other departmental and cross-functional projects and assignments given by the manager.

Education and Experience

Possess a bachelor's degree in chemistry, Pharmaceutical Sciences, or related field of study from an accredited institution. Master's degree in the above and/or related fields of study as noted above preferred.

A minimum of eight (8) years (preferable 8-15years) of relevant work experience in a pharmaceutical manufacturing setting within the Quality function.

Must be proficient in computer skills and software applications such as Microsoft Office tools and Quality applications and software programs.

Minimum of five (5) years' experience in quality assurance in a cGMP pharmaceutical manufacturing operation environment.

Current, working knowledge of analytical quality assurance (AQA).

Strong knowledge and experience with analytical laboratory activities in areas such as active pharmaceutical ingredients (API), drug products, analytical development, Quality Control (QC), Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP)/Good documentation Practices (GDP), USP monograph requirements, FDA & ICH guidance requirements, etc.

Technical Knowledge and Computer Systems Skills

Understanding of laboratory equipment operation, qualification and calibrations which includes their software audit trial reviews. E.g. HPLC, UV Vis Spectrophotometer, GC, Potentiometer, pH meter, Stability chambers, etc.

Strong knowledge on USP monograph requirements, FDA & ICH guidance requirements, etc.

Must be able to influence decision making and facilitate completion of work towards the achievement of the business plan and goals.

Effective interpersonal relationship skills and the ability to work in a team environment.

Capable of conducting troubleshooting, investigations and root cause identification and analysis.

Capable of supporting and participating in compliance and regulatory audits at the local and federal levels.

Experience in Inhalation products (MDI) is a plus.

Ability to work in a fast-paced, dynamic environment within a manufacturing operation setting.

Must be able to communicate clearly and concisely across all levels of the organization and possess a solid command of English language communication skills verbally, written, and interpersonally.

Must possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices.

Must be able to work under minimal supervision and able to work independently and in a team environment.

Professional and Behavioral Competencies

Proficiently speak English as a first or second language and ability to read, write and communicate effectively the same.

Must be a self-starter and demonstrate initiative to seek additional training or direction as needed.

Must be willing and able to work any assigned shift ranging from first or second shift; work schedules may be Monday to Friday.

Knowledge of good manufacturing practices and good documentation practices preferred.

Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.

Excellent organizational skills with the ability to focus on details.

Work Schedule and Other Position Information:

Must be willing to work in a pharmaceutical manufacturing setting.

General shift but must be willing and able to work any assigned shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs.

Must be willing to work some weekends based on business needs as required by management.

Relocation negotiable.

No remote work available.

This role works in cGMP laboratory or manufacturing environment, where personal protective equipment (PPEs) is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc.

The role may be assigned on a work Weekend or Holiday work may be requested or required based on business needs.

Assessing and implementing of Pharmacopoeia changes whenever any new edition, supplement, amendment, or other changes of any Pharmacopoeia are in effect.

Performing other departmental and cross-functional projects and assignments given by the manager.

Education and Experience

Possess a bachelor's degree in chemistry, Pharmaceutical Sciences, or related field of study from an accredited institution. Master's degree in the above and/or related fields of study as noted above preferred.

A minimum of eight (8) years (preferable 8-15years) of relevant work experience in a pharmaceutical manufacturing setting within the Quality function.

Must be proficient in computer skills and software applications such as Microsoft Office tools and Quality applications and software programs.

Minimum of five (5) years' experience in quality assurance in a cGMP pharmaceutical manufacturing operation environment.

Current, working knowledge of analytical quality assurance (AQA).

Strong knowledge and experience with analytical laboratory activities in areas such as active pharmaceutical ingredients (API), drug products, analytical development, Quality Control (QC), Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP)/Good documentation Practices (GDP), USP monograph requirements, FDA & ICH guidance requirements, etc.

Technical Knowledge and Computer Systems Skills

Understanding of laboratory equipment operation, qualification and calibrations which includes their software audit trial reviews. E.g. HPLC, UV Vis Spectrophotometer, GC, Potentiometer, pH meter, Stability chambers, etc.

Strong knowledge on USP monograph requirements, FDA & ICH guidance requirements, etc.

Must be able to influence decision making and facilitate completion of work towards the achievement of the business plan and goals.

Effective interpersonal relationship skills and the ability to work in a team environment.

Capable of conducting troubleshooting, investigations and root cause identification and analysis.

Capable of supporting and participating in compliance and regulatory audits at the local and federal levels.

Experience in Inhalation products (MDI) is a plus.

Ability to work in a fast-paced, dynamic environment within a manufacturing operation setting.

Must be able to communicate clearly and concisely across all levels of the organization and possess a solid command of English language communication skills verbally, written, and interpersonally.

Must possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices.

Must be able to work under minimal supervision and able to work independently and in a team environment.

Professional and Behavioral Competencies

Proficiently speak English as a first or second language and ability to read, write and communicate effectively the same.

Must be a self-starter and demonstrate initiative to seek additional training or direction as needed.

Must be willing and able to work any assigned shift ranging from first or second shift; work schedules may be Monday to Friday.

Knowledge of good manufacturing practices and good documentation practices preferred.

Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.

Excellent organizational skills with the ability to focus on details.

Work Schedule and Other Position Information:

Must be willing to work in a pharmaceutical manufacturing setting.

General shift but must be willing and able to work any assigned shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs.

Must be willing to work some weekends based on business needs as required by management.

Relocation negotiable.

No remote work available.

This role works in cGMP laboratory or manufacturing environment, where personal protective equipment (PPEs) is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc.

The role may be assigned on a work Weekend or Holiday work may be requested or required based on business needs.