Sr. Manufacturing Quality Assurance

Additionally, the Senior Quality Engineer supports on-going production including by working with operations/quality teams for deviation resolution, auditing of commissioning and validation documentation completed by others, authoring and execution of newly identified qualification/validation protocols, review and approval of critical planned maintenance routines, and other quality assurance tasks assigned by the MQA Section Manager and/or the Plant QA Manager. The Senior Quality Engineer will provide Quality support for projects related to core production, new software/computer systems, new products/technologies/Automation systems.

This is 100% onsite M-F 8 am - 5 pm; Rotating weekly on-call shifts for evenings and weekend.
100% Onsite

Top 3 5 Skills Needed for each role
1. Quality System and Regulatory Knowledge - Strong knowledge of ISO 13485, !SO 14971 and FDA 21 CFR part 820/QSMR
2. Risk management and FMEA understanding
3. Technical problem Solving and Root cause analysis expertise
4. Communication and Cross-Functional Influence
5. Manufacturing Quality Experience and process knowledge

Job Description Senior Quality Engineer
The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant. The Senior Quality Engineer will provide Quality support for projects related to core production, new software/computer systems, new products/technologies/Automation systems. As part of the project team, the Senior Quality Engineer will ensure all activities including Qualification/Validation Strategy, Deviation Investigation and Resolution, Risk Management activities, etc. meet applicable Quality and Regulatory requirements.
Additionally, the Senior Quality Engineer supports on-going production including by working with operations/quality teams for deviation resolution, auditing of commissioning and validation documentation completed by others, authoring and execution of newly identified qualification/validation protocols, review and approval of critical planned maintenance routines, and other quality assurance tasks assigned by the MQA Section Manager and/or the Plant QA Manager.

Responsibilities

• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Support the site to ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.
• Provide Quality support on project work related to Equipment installation/Computer Systems/Automation Systems while ensuring compliance with applicable regulations/standards. Lead project activities related to Quality and Compliance. Support Core production/ process improvement projects as assigned.
• Oversee data integrity initiatives to ensure security, accuracy, consistency, and completeness of data throughout system usage.
• Support the Risk Management process throughout all quality system elements such as Design Control, Product Surveillance, Field Action, etc. Update risk management file documents as needed.
• Ensures investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Performs product impact analyses for plant events and places product on QA hold where appropriate.
• Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments including remote off-shift support as required.
• Approves standard operating procedures; ensures procedures comply with policies and regulations.

Qualifications

• Bachelor's degree, preferably in Biology, Chemistry or Engineering
• 6+ years of overall experience in Manufacturing, Quality or Engineering
• Good verbal and written communication skills.
• Good problem solving and analytical skills
• Good interpersonal relations / communications skills
• Good negotiation skills
• Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.

Preferred

• Experience in manufacturing within pharmaceutical, medical device, biotechnology and food industry with cGMP is highly desirable
• Experience with implementing and maintaining the effectiveness of the Quality System.