Quality Assurance Technician - Nights

Adare Pharma Solutions; Vandalia (OH); On-site; USD 50,000 - 70,000; Full time

Job summary

Adare Pharma Solutions is looking for a Quality Assurance Technician to join their Quality team in Vandalia, Ohio. The role involves providing quality support on the manufacturing floor, auditing documentation, and ensuring compliance with cGMP. Candidates should possess an Associate's Degree in a related field and have 3+ years of experience in the pharmaceutical industry. This position offers opportunities for growth and development within a company dedicated to enhancing patient lives.

Benefits

Medical/dental/vision/life – low employee premiums

401k with a highly competitive match

Generous PTO, including floating holidays

Career growth and internal opportunities

Tuition reimbursement

Relocation assistance

Performance-based bonus

Employee Recognition Programs

Qualifications

• Associates Degree preferred with 3+ years in a regulated industry.
• Knowledge in cGMP preferred regarding records and documentation.
• Auditing experience required.

Responsibilities

• Provide quality support on the manufacturing floor.
• Audit batch production documentation and ensure compliance.
• Review and close incident reports.

Skills

Accuracy and neatness

Oral and written communication skills

Auditing

Education

Associates Degree in pharmaceutical sciences, chemistry, biology

Job description

Vandalia, Vandalia, Ohio, United States of America

Job Description

Posted Thursday, June 5, 2025 at 10:00 AM

Are you ready to join a growing, global drug development and manufacturing organization that puts people first? Come to Adare! We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world. Every role within Adare offers you a unique, customized experience with a chance to make a real impact that is critical to our success. With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery!

Join our mission at Adare!

What can Adare offer you?

• Medical/dental/vision/life – low employee premiums
• 401k with a highly competitive match
• Generous PTO, including floating holidays
• Career growth and internal opportunities
• Tuition reimbursement
• Relocation assistance
• Performance-based bonus
• Employee Recognition Programs

We are seeking to hire a Quality Assurance Technician to join our Quality team…
If any of the below describes you, we would love to meet you!

JOB SUMMARY
This position is responsible for providing quality support to the manufacturing floor, auditing batch production documentation, dispositioning intermediates and equipment after cleaning, performing in process checks, reviewing and approving incident reports, reviewing finished product records, revise quality documents (e.g. SOP, protocols, methods), and ensuring adherence to cGMP.

RESPONSIBILITIES AND LEARNING OPPORTUNITIES
• Partner with Operations employees to document incidents, and resolve other outstanding plant quality/compliance issues.
• Provide Quality support on the manufacturing shop floor.
• Escalate issues found during walkthroughs to management.
• Perform assessments during operations activities to ensure all work is performed in compliance with GMP, SOP and regulatory requirements.
• Issue batch production and cleaning records.
• Audits production logbooks
• Disposition equipment after cleaning.
• Review executed Production Records (Intermediate and Finished), , and Analytical results for compliance to established internal procedures, methods, specifications, and industry standards.
• Resolves minor issues found during documentation review (documentation errors, missing information) as directed by SOP.
• Conduct product release activities for intermediates.
• Identify incidents, log events, and notify affected departments of the incidents
• Review and close incident reports.
• Determine if incidents need further investigation/escalation.
• Enter investigations into access database.
• Participates on project teams as assigned by management.
• Propose and author departmental procedures changes consistent with objectives of simplification and process efficiencies/improvements which ensure ongoing compliance.
• Train QA Technician I and II as assigned
• Completes all assigned training by target due dates.
• Files GMP documentation.
• Interface with all departments within the company.
• Be an ambassador for Quality within the company.
• Maintain professional interactions with all departments and other sites.
• Ensure facility adherence to cGMP.
• Work as part of the Quality Assurance team to meet company, departmental, and individual goals as outlined by management.
• Follow other job-related instructions and perform other tasks as required.

REQUIRED SKILLS AND QUALIFICATIONS
• Associates Degree preferred in a related field (i.e. pharmaceutical sciences, chemistry, biology) with 3+ years of experience in the pharmaceutical or other regulated industry.
• Knowledge in cGMP as related to records and documentation in a pharmaceutical manufacturing environment preferred
• Auditing experience required.
• Accuracy and neatness of compiling documents are required.
• Good oral and written communication skills.

PHYSICAL REQUIREMENTS:
The employee is required to stand, walk, push, pull, twist, reach overhead, and bend to the floor, have visual sharpness for reading written instructions and computer screen, and is subject to office, production and warehouse environments.

Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.

PRINCIPALS ONLY
NO AGENCIES OR THIRD PARTIES

Attention Job Seekers and Applicants: Please be aware of attempted recruiting scams. While Adare does conduct virtual interviews for some positions, we do NOT use Skype or Google Meet. If you are contacted by someone regarding a job opportunity, please be vigilant in reviewing the details of any and all correspondence. Here are some things to look out for: bad grammar; font inconsistencies or formatting irregularity: logos not properly sized, stretched out, blurred; numerous different font styles and sizes within the content of an email or letter; company impersonators (postings that mirror a reputable company, but there’s no link to the business) mismatched email or website domains, or there is difficulty with locating an address, business phone number, and/or email address, financial requests: Do not provide payment or account credentials as part of the application process. Legitimate companies should not require transfers, checks, gift cards or the wiring of funds as a condition of the application process. Additionally, equipment purchases: be cautious if a company asks you to purchase your own equipment (computers, iPads, mobile phones) and requests you to mail it to their IT department. Applicant Follow-up Questions: Proceed with caution if you receive an application follow-up request that requires you to click on a link to answer additional questions; especially if the questions request personal information such as a social security number. General anonymity: proceed with caution if you can’t quickly verify the identity of the poster.

Vandalia, Vandalia, Ohio, United States of America