QC Analyst II - Document Reviewer

Overview:

TekWissen group is a workforce management provider throughout the USA and many other countries in the world. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.

Job Title: QA Specialist II

Location: Tampa FL 33634

Duration: 6 Months

Job Type: Contract

Work Type: Onsite

Shift timings: 2nd shift hours - 3pm-11:30pm

Description:

Key Accountabilities

• Performs document reviews of SOPs, batch records, test methods, protocols, deviations, CAPA, component specification and logbooks to ensure cGMP activities are completed and documented in accordance with approved, written procedures.
• May also review raw materials, work orders, validation and MSAT reports.
• Approves SOPs, Master Batch Records and executed batch records.
• Approves / Releases Laboratory Data and Reports.
• Assesses potential impact to product quality for open deviations during lot release.
• May participate in investigations into minor and major root cause, corrective or preventive actions and impact to product safety, identity, strength, quality or purity.
• Participates in internal audits, vendor audits and customer audits.
• Provides back room support during regulatory audits and inspections. May lead internal or external audits.
• Interact with different departments to solve issues to achieve department goals.
• Support all areas to achieve company goals.
• Attend client meetings and calls
• Perform additional job-related assignments as requested by management
• Adhere to all defined Safety and Sustainability requirements and expectations and seek clarification whenever Safety and Sustainability requirements and expectations are either unknown or unclear
• Promptly report identified Safety and Sustainability issues, problems, deficiencies, errors, incidents, and/or opportunities to management and correct where possible
• Stop work where deemed necessary to maintain safety

Minimum Education Level Required:

• Bachelors

Preferred Field of Study:

• Science

Minimum Years Required Experience:

• 3

Preferred Field of Experience:

• Pharma cGMP

TekWissen® Group is an equal opportunity employer supporting workforce diversity.

Job Type: Contract

Salary: $42.00 - $45.00 per hour

Schedule:

• 8 hour shift
• Day shift

Work setting:

• In-person

Application Question(s):

• How many years of experience do you have as a QC Chemist?
• Do you have experience working in cGMP environment?
• How many years of experience do you have in analytical testing?
• How many years of experience do you have in lab testing and documentation?
• Have you ever performed the CAPA deviations and investigations?

Work Location: In person