Technical Operations Specialist

Responsible for generating and/or review manufacturing related technical documents and manage timely closure of these documents. This includes but is not limited to Non-Conforming Event (NCE) investigations, CAPAs, Change Controls
(CC), Batch Records (BR), Technical Transfers (TT), Final Reports (FR), and Standard Operating Procedures (SOP).

Responsibilities:

• Understands aseptic technique concepts
• Able to identify unacceptable practices and implement improvements
• Understands basic operations and functions of equipment
• Understands the maintenance of equipment
• Understands basic solution and material preparation
• Possesses basic technical knowledge and background in the pharmaceutical and biotechnology industry
• Possesses basic and fundamental engineering and mechanical knowledge and is able to apply in the manufacturing area
• Possesses basic and fundamental understanding of technical transfer activities
• Ideally, understands the application of GMP concepts and is able to recommend and identify improvements as the process develops during phases of technical transfer
• Possesses basic and fundamental understanding of validation activities
• Possesses basic and fundamental understanding of material related activities
• Possesses some proficiency on Master Control
• Possesses some proficiency on NovaTek
• Possesses basic and fundamental understanding of support systems (e.g. LIMS)
• Understands the concept of manufacturing processes and methods
• Identifies, understands and able to explain the ‘why’ of acceptable and unacceptable practices, is able to make suggestions to improve performance
• Performs basic analysis, interprets, and draws conclusion of scientific and process data per good document practices
• Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and understands ‘why’ behind the regulations.
• Identifies, communicates, addresses and improves simple cGMP compliance and regulatory gaps and issues
• Follows and executes Standard Operating Procedures (SOPs)
• Revises, authors and provides comments as a reviewer to simple SOPs
• Improves the efficiency and execution of SOPs
• Improves the efficiency and right-first-time (RFT) of BR execution
• Participates, provides information in the development of and authors basic technical documents such as non conforming events, deviations, CAPA’s, action plans and change control
• Possess basic computer skills and able to efficiently use basic Microsoft applications
• Suggests, participates and implements continuous improvement ideas
• Identifies, participates, suggests with options, recommends path forward and leads basic decision making
• Participates, supports, presents and represents as an SME during regulatory inspections and client audits
• Interacts frequently with support groups
• Regularly coordinates with groups
• Cross trains in other areas and may be utilized to perform above job functions across the entire site
• Performs well under minimal supervision and starts to work independently on basic tasks and processes
• Ideally, possesses lean/six sigma knowledge and experience
• May be required to work Holidays and weekends
• May be required to work overtime / outside of normal business hours
• Other duties as assigned

Qualifications:

• Associates’/Bachelor’s (science preferred) degree with 0-1 years of relevant or equivalent experience or
• High School diploma and 2-4 years of relevant experience or

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Relocation assistance
• Tuition reimbursement
• Vision insurance

Schedule:

• Day shift
• Monday to Friday

Supplemental Pay:

• Bonus pay
• Signing bonus

COVID-19 considerations:
We are following all CDC guidelines for the City of Philadelphia. Our Employee safety is our #1 priority.

Ability to commute/relocate:

• Philadelphia, PA 19112: Reliably commute or planning to relocate before starting work (Preferred)

Work Location:

• One location

Work Remotely:

• No

Work Location: One location