Job Functions1. Quality Assurance2. Manufacturing Support3. Documentation Review and Approval4. Continuous Improvement Initiatives5. Auditing
Job Requirements1. High School Diploma Required; Bachelor’s degree STEM Sciences preferred, or equivalent experience2. At least a 2 years’ experience within the biologic, biopharmaceutical, or regulated industry.3. Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.4. Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification, and fill/finish.
Skills1. Good Manufacturing Practices (GMPs)2. 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s3. ICH Guidelines4. EU GMPs5. Biological manufacturing processes1. Strong communication skills2. Attention to detail3. Analytical thinking4. Problemsolving skills5. Continuous improvement mindset
Job Summary:
This role provides Quality Assurance support for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption.
Responsibilities:
- Performs QA on the Floor activities supporting client projects, including room release, observing critical processes, reviewing batch documentation in real time, cleaning documentation, logbooks and resolving issues that occur during manufacturing.
- Perform Acceptable Quality Limit (AQL) visual inspection of drug product.
- Review and approve batch documents for media and buffer prep solutions.
- Generate or revise GMP documentation such as Standard Operating Procedures, Master Batch Record review and SMP’s.
- Compile deviations as required when observed on the floor and move to completion within the required time frame.
- Provides dedicated QA quality floor oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product – 70% of day is spent on the floor.
- Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices
- Identify and implement and continuous improvement initiatives. Participate in site and corporate quality and process improvement initiatives.
- Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements, and industry best practices.
- Other duties as assigned.
Qualifications:
- High School Diploma Required; Bachelor’s degree -STEM Sciences preferred, or equivalent experience
- At least a 2 years’ experience within the biologic, biopharmaceutical, or regulated industry.
- 2 Years’ experience in Manufacturing/Quality Assurance/Quality Control function preferred.
- Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.
- Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification, and fill/finish.
Physical Requirements:
- Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors. May be given a visual exam for visual acuity and color perception.
- Must communicate fluently in English and have legible handwriting.
- Ability to travel between and within facilities to visit staff, operations, projects, etc.
- Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
- Ability to lift up to 30 pounds regularly.
- May require up to 5% travel, based on business need
26.00 To 34.00 (USD) Annually
Life at Pharmaceutics International
Pii (Pharmaceutics International, Inc) is a multinational contract formulation and pharmaceutical development, Clinical Trial Materials (CTM), and commercial manufacturing company with corporate headquarters in Hunt Valley, Maryland, USA. Founded in 1994, Pii manufactures a wide range of dosage forms covering solid, semi-solid and aseptic filling. This service is complemented by full analytical and regulatory support.
Thrive Here & What We Value- Collaborative work environment that fosters sharing of ideas- Diverse customer and employee base (internally and externally)- Emphasis on quality standards and compliance with regulatory requirements- Adheres to Pii policies and procedures in carrying out maintenance assignments achieving excellence in timeliness, quality of work, documentation, inspection, and communicating skills.- Responsible for following all relevant regulations (e.g., FDA, OSHA, EPA, etc.)- Demonstrates ability to comprehend and follow all applicable SOPs- Results-oriented and efficient- Creative and open-minded who fosters an environment in which sharing of ideas is encouraged- Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally)- Ability to work well in a cross-functional team environment- Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment- Demonstrates excellent personal organizational skills.- Selfmotivated and team-oriented with the ability to work with minimal supervision and limited direction.- Can accommodate nonroutine work schedules, and be able to respond to call-ins.- Good understanding of cGMPs, industry, and regulatory standards and guidelines.</s>
