Job Summary:

Become the subject Matter expert for Compliance as related to Production Operations. Responsible for assiting personnel with the completion of Incident / Deviation investigation process as well as the generation and or updating of pertinent Production related documentation. Provide Quality Assurance support to stake holders from various departments to assist with completion of such tasks as validations, qualifications, documentation updates, investigations and or projects.

Working with Production, perform initial assessment to determine if a production line may or maynot resume production after the identifcation of an event.

The position requires the ability to multi task, meet timelines, and maintain cross-functional interactions with key stake holders (Technical Services, Engineering, Quality Control and Production).

The position may involve the review and approval of validation of analytical methodology (protocols and reports), specifications, master batch records, executed batch records, formulation spreadsheets and Standard Operating procedures (SOPs) in support of research projects involving pharmaceutical components and/or drug products ensuring compliance with cGMP's, company procedures and regulatory commitments.

Job Responsibilities

• Initiates, reviews and completes Investigations for product quality deviations and customer complaints.
• Reviews validation and qualification documents.
• Becomes Subject matter expert for company product line, production equipment, batch records and relevant SOPs.
• Reviews and analyzes documents and data such as batch records, lab testing, finished product material statuses so as to support completion of the investigation process.
• Serves as an investigation team leader so as to assess impact on product quality and validation status.
• Recommends and monitors improvements in manufacturing and control systems including corrective and preventative actions (CAPA).
• Is able to concisely summarizes the results of an Investigation in writing.
• Works together with multiple departments to troubleshoot the production processes and identify process improvement opportunities.
• Ensures compliance with GMPs.
• Provides training and mentoring to colleagues performing investigations.
• Writes/revises SOPs relevant to the positions responsibilities.
• Working with the Production Quality team, assess events when they arise to determine ability to resume production.
• Interpret specifications, standard operating procedures, and standard testing procedures.
• Responsible for the review and approval of validation of analytical methodology (protocols and reports), specifications, master batch records and executed batch records, formulation spreadsheets in support and Standard Operating procedures (SOPs) in support of research projects involving pharmaceutical components and/or drug products components and/or drug products.
• Performs assessments / approvals of change controls related to production activities.
• Attends Daily Leadership Meetings so as to provide updates as well as take away any actions for Quality required to be communicated.
• Ensures compliance with all Company policies and procedures including safety rules and regulations.
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion
• All other relevant duties as assigned.

Job Requirements

• Education

A Bachelors degree in Engineering or Life Sciences from an accredited college or university with a minimum of 5 - 8 years experience or a Masters degree and 3-5 years of experience in a cGMP regulated manufacturing environment or an equivalent combination of training and experience is required. Preferred Bachelors degree (B.S.) in chemistry or related field with at least 5-8 years of experience in pharmaceutical analytical laboratory with transdermal laboratory experience, or Masters degree (M.S.) with at least 3-5 years of experience.

• Required Knowledge, Skills and Abilities
• Knowledge of GMPs (21CFR Parts 210 and 211)
• Analyzing and troubleshooting problems, identifying root causes and recommending and implementing effective methods, procedures, systems and/or techniques.
• Ability to prepare / edit all types of pharmaceutical documentation (batch records, SOPs, protocols, summary reports, etc.)
• Sound knowledge of the Health Canada, FDA, and other pharmaceutical regulations.
• Thorough understanding of GMPs, specifically those relating to good documentation practices.
• Ability to analyze and interpret analytical data.
• Interpret specifications, standard operating procedures, and standard testing procedures.
• Strong organizational skills
• Managing multiple projects, duties and assignments.
• Writing and interaction in English.

• Preferred Knowledge, Skills and Abilities
• Knowledgeable in multiple instrumentation techniques such as HPLC, GC, UV-VIS, dissolution equipment, pH measurement, titration, etc.
• Knowledgeable in analytical testing of API, excipients and components following compendial and validated methods.
• Analytical chemistry and common instrumentation

• Experience

Minimum of 5 - 8 years experience in a cGMP regulated manufacturing environment or an equivalent combination of training and experience is required. Preferred minimum of 5-8 years of experience in pharmaceutical analytical laboratory with transdermal laboratory experience