POSITION SUMMARY The Quality Associate I, Operations is responsible for actively participating in “on the floor” Quality activities during product manufacturing and/or packaging. Quality activities include pr…
Skills: Product Sampling, Physical Inspection, GMP Compliance, Line Clearance, Non-Conforming Event Support
Job Description: Primary responsibilities of this role include the following: With Supervision, review documents/records and provide batch release authorization to 3PL service provider for products manufactured outside o…
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$22/hr–$26/hr
Full-time
high school
Posted 2d ago
~40 hrs/week
Responsibilities
The Associate I, Quality Operations performs on-the-floor quality activities including product sampling, inspection, and area clearance during manufacturing and packaging. They are also responsible for supporting non-conforming event investigations and collaborating on continuous process improvement initiatives.
Requirements
Candidates must have a high school diploma and 2-4 years of relevant industry experience, preferably in Oral Solid Dose pharmaceutical manufacturing. Required skills include strong documentation abilities, attention to detail, and the ability to interpret SOPs and Batch Production Records.
Full job description
POSITION SUMMARY
The Quality Associate I, Operations is responsible for actively participating in “on the floor” Quality activities during product manufacturing and/or packaging. Quality activities include product sampling and inspection, area clearance to confirm process readiness, non-conforming event support to resolve in-process issues. Communicates to multiple departments and supervision to provide timely process and issue updates. Identifies and escalates issues or problems to appropriate supervision. Participates as a team member on cross-functional teams. Participates in reviews and structured processes for continuous improvement.
ESSENTIAL FUNCTIONS
Quality Operations
Performs physical inspection of in-process and finished product samples as assigned and according to the production schedule.
Collects samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirements
Follows internal processes related to controlled substances
Performs GMP-related verifications such as line clearances, cleaning, room inspection, and materials.
Collects and appropriately labels packaging retain samples, and submits to the archive storage.
May execute computer data entries in CME, JDE, LIMS, and department databases
Collects retain samples and performs sample evaluation for Annual Product Review
May backup third party product review/release
Perform sampling of Active Pharmaceutical Ingredients, excipients, and packaging components or release testing
Non-Conforming Events
Responds to and escalates events identified during production to Quality Management
Participates in investigations with the Rapid Response Team as needed
Process Improvement
Collaborates with Manufacturing and Quality partners to identify and implement improvements
Compliance
Conducts GMP walkthroughs of facilities
Learns how to perform in-process audits to identify adherence to SOPs and BPR requirements
Actively participates in training events, and maintains currency with assigned training requirements
Safety
Follows all procedures to ensure a safe and compliant work environment.
QUALIFICATIONS
Education & Experience
High school diploma or equivalent with 2-4 years’ relevant industry (Oral Solid Dose pharmaceutical manufacturing and Quality Assurance experience preferred)
Knowledge & Skills
Ability to communicate and work with teams
Attention to detail
Strong documentation skills
Ability to read and interpret SOPs and function within the scope of procedures
Proficiency with basic math skills and basic experience with computers and software applications required
Ability to learn new processes and procedures
Able to communicate effectively with other departments, management and operational personnel
Customer/Stakeholder focused (understands impact of daily work to compliance and overall business)
Proof-reading skills; ability to identify errors
Ability to read and comprehend documentation and requirements set forth in Batch Production Records (BPRs)
Experience with Enterprise Resource Planning (ERP) system is a bonus
Ability to work overtime as needed, including occasional weekend shifts
Official account of Strides Pharma Science Limited, a global pharmaceutical company headquartered in Bengaluru, India.
Industry
Pharmaceutical Manufacturing
Company size
1,001-5,000 employees
Founded
1990
Headquarters
Bangalore, Karnataka
LinkedIn followers
145,175
Total funding
$33M
Strides Pharma Science is a global pharma company headquartered in Bengaluru and a footprint across 100 countries. We operate two business verticals, Regulated Markets and Emerging Markets. Our manufacturing footprint covers 8 manufacturing facilities in 4 continents, including 5 US FDA approved facilities and a dedicated R&D facility in India with global filing capabilities. Our core competence is in the development and manufacture of wide range of niche and technically complex pharmaceutical products. We are also among the world's largest soft gelatin capsule manufacturers. For more details, please visit www.strides.com
Offices: Strides House, Opposite IIM-B, Bannerghatta Main Road, Bilekahalli, Krishnaraju Layout, Amalodbhavi Nagar, Panduranga Nagar, Bangalore, Karnataka 560076, IN
Official account of Strides Pharma Science Limited, a global pharmaceutical company headquartered in Bengaluru, India.
Industry
Pharmaceutical Manufacturing
Company size
1,001-5,000 employees
Founded
1990
Headquarters
Bangalore, Karnataka
LinkedIn followers
145,175
Total funding
$33M
Strides Pharma Science is a global pharma company headquartered in Bengaluru and a footprint across 100 countries. We operate two business verticals, Regulated Markets and Emerging Markets. Our manufacturing footprint covers 8 manufacturing facilities in 4 continents, including 5 US FDA approved facilities and a dedicated R&D facility in India with global filing capabilities. Our core competence is in the development and manufacture of wide range of niche and technically complex pharmaceutical products. We are also among the world's largest soft gelatin capsule manufacturers. For more details, please visit www.strides.com
Offices: Strides House, Opposite IIM-B, Bannerghatta Main Road, Bilekahalli, Krishnaraju Layout, Amalodbhavi Nagar, Panduranga Nagar, Bangalore, Karnataka 560076, IN