Lab Investigations Specialist - Pharmaceutical Industry

Department: Quality Control

Job Title: Lab Investigations Specialist

1. Role Purpose:

Primary responsibility is to complete assignments in a timely manner while maintaining compliance with cGMP requirements, FDA, OSHA, EPA, DEA and/or any other local or international regulatory agency. Testing and documentation will be delegated through the Senior Manager.

1. Lead the Quality Control Investigation team in support of commercial and Stability testing programs.

2. Support Laboratory Quality Systems including change control, investigations and documentation practices as part of the quality and compliance objectives.

3. Provide oversight, and expertise to maintain compliance with equipment calibration and Preventative Maintenance schedules.

4. Provide technical and managerial assessment and input on quality documentation including all validation and process improvement protocols / reports and closed identified gaps.

2. Key Duties & Responsibilities:

• Reviews all lab data
• Checks data integrity
• Trends data
• Analyzes data
• Organizes laboratory notebooks and data
• LIR, OOS, OOT investigations
• Coordinates with QC laboratory personnel
• Handles and completes special projects as required
• Conduct timely and thorough laboratory investigations, ensuring compliance with departmental SOPs and FDA guidelines.
• Author and review investigations, proposed CAPAs, investigational protocols and reports ensuring conclusions and actions are appropriate for the identified root cause.
• Conduct investigational and/or remedial testing as required.
• Guide assigned personnel in conducting thorough, compliant laboratory investigations.
• Provide weekly summaries of lab incidents and investigations to the Investigational Review Board.
• Communicate activities and status on laboratory investigations as required.
• Drive productivity improvements while maintaining high quality standards.

· Follow and enforce compliance with cGMP (current Good Manufacturing Practices), GLP (Good Laboratory Practices), 21CFR211.22, 21CFR211.28 and 21CFR211.170 regulations.

• Ensure all QC Laboratory Investigation records and documentation are maintained as per cGMP and 21CFR211.194 guidelines. Ensure Data Integrity.

· Follow and enforce all DEA (Drug Enforcement Agency) guidelines

• Author, and review Investigational, Analytical, Cleaning Validation protocols and reports, SOPs, CAPAs and other documents.
• Support review of analytical methods, and specification revisions
• Ensures that SOP’s, guidelines and company policies are readily available and training requirements are met on time and kept up to date by the chemists and staff.
• Responsible for improving and conducting training in analytical techniques, documentation and regulations especially those connected with laboratory investigations.

· Follow the OSHA (Occupational Safety and Health Administration) and EPA (Environmental Protection Agency) safety regulations.

· Ensures that the all-laboratory team leaders, chemists, staff members and visitors adhere to all safety procedures and identifying/communicating the necessary adjustments to address potential safety concerns. The manager will also ensure the team leaders are enforcing the proper wearing of PPE (personal protective equipment).

• Identifies and addresses employee development needs based upon performance assessments and feedback from team leaders.
• Drive productivity improvements while maintaining high quality standards.
• Supports attainment of team leader goals

· Work with Microsoft Excel, Word, and possibly PowerPoint

· Handle and complete special projects as required

· Create and manage administrative documents (electronic/hard copy) as needed

· Other duties as required or delegated

3. Typical Supervisory Responsibility:

· This position will require interviewing, hiring, training and development of department personnel.

· This position will have direct report(s), requiring oversight, development and performance review activities.

4. Education & Experience:

Must have a BS or MS degree preferred

5. Technical competencies/ Certifications/ Licenses:

·Working knowledge of HPLC, UPLC, GC Dissolution, AA, UV spectrophotometer

·Aptitude for application of analytical methods

·Proficiently skilled in laboratory techniques

·Ability to work independently under the supervision of a manager

· Takes initiative on assignments and day to day responsibilities

· Proficient in personal computers

· Excellent interpersonal and communication skills

· Organization

·Continuous working knowledge of applicable cGMP guidelines

·Continuous working knowledge of applicable DEA regulations

· Experience in GMP Quality Control Laboratory Management.

· Proven knowledge in QC/Analytical Laboratory Instrumentation and Raw Material (API’s, Excipients, Packaging components) Testing.

· Minimum of 10 years of experience in the pharmaceutical industry

· Working knowledge of HPLC, UPLC, GC Dissolution, AA, UV spectrophotometer and other instrumental and wet chemistry techniques.

· Aptitude for application of analytical methods

· Knowledge of USFDA, ICH, cGMP, cGLP, Safety guidelines

· Critical thinking skills

· Good verbal and written English

· Excellent interpersonal, verbal (listening and speaking) and written communication skills

· Effectively performs a variety of duties, on schedule, with accuracy and competency.

· Serves as an effective member of the Quality team and may serve as a mentor to other Quality employees in their area of expertise.

· Experience in statistical analysis, process capability reviews with software

· Ability to act independently

6. Physical demand and Work environment:

a. Physical demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.

b. Work environment:

N/A

Job Type: Full-time

Pay: From $1.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Newtown, PA 18940: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location