QA Batch Record Specialist - 3rd Shift

QA Batch Record Specialist role supports fast-paced production environment to ensure controlled documents are managed as per standard processes and that product quality meets internal and regulatory requirements for release.

Requirements

• High School diploma or GED required
• Minimum one (1) year of experience in an FDA-regulated manufacturing facility required
• Ability to read and interpret documents in the English language required
• Ability to perform calculations in all units of measure and understand rounding rules, significant figures, and tolerances to determine compliance with established criteria required
• Ability to use PC, calculator, and basic software (i.e., Microsoft Office); GMP software (e.g., Agile PLM, Oracle) experience preferred
• Ability to read and follow written policies/procedures for cGMP, SOP, and Safety guidelines required
• Ability to lift up to 25 pounds
• Adequate vision to read controlled documents accurately
• Must be detail-oriented and organized to work in a fast-paced environment and adapt to changing priorities to meet operations demands
• Ability to work both independently and as a member of a team
• Strong interpersonal skills to communicate effectively with all departments at all levels within the organization via multiple communication mediums as required

Benefits

• Medical and Dental Benefits
• 401K with employer match
• Group Life Insurance
• Flex Spending Accounts
• Paid Time Off and Paid Holidays
• Tuition Assistance
• Corporate Discount Program