Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowPosted 4 days ago

QA Batch Record Supervisor

American Regent, Inc.101 open roles

Where
New Albany OH
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowQA Batch Record SupervisorAmerican Regent, Inc. · New Albany OH

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on American Regent, Inc.'s own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

12.8% of postings close within 7 days. Measured by our own scanner across the market. American Regent, Inc. postings stay open a median of 43 days.

Share of postings closed within
  1. 2.2%1 day
  2. 4.5%3 days
  3. 12.8%7 days
  4. 20.6%14 days
  5. 35.6%30 days
  6. 58.4%60 days
This job: posted 4 days ago

American Regent, Inc. median: 43 days open

The posting

Nature and Scope

This position is responsible for ensuring the overall quality in their assigned areas through the execution of site policies and procedures, programs, and work instructions. Ensures all documentation, processes and products meet specifications and that Batch Records are completed in accordance with GMP requirements. The QA Batch Record Supervisor is responsible to provide direction and support to the Batch Record Review group as associated with the manufacture of safe, pure, effective, and sterile pharmaceuticals in accordance with company Standard Operating Procedures (SOP’s). This position requires effective collaboration with other departments on production issues/situations, product dispositions and investigations into root causes for deficiencies. The Batch Record Review Supervisor is directly responsible for training, and support performance assessment of QA Batch Record Reviewers (I, II, and III). The Supervisor ensures QA Batch Record Reviewers maintain compliance with quality programs. The Supervisor is responsible for managing the workflow of documentation withing the department.

Essential Duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

· Maintain quality objectives and conduct accurate verifications, including but not limited to, identifying batch record gaps, reporting and escalating issues, developing corrective actions, sampling plans, accurate documentation assessments.

· Supervise QA Batch Record Reviewers (I, II, III) on department support, including scheduling, training, coaching and mentoring.

· Partner with personnel to resolve errors and/or discrepancies according to SOP requirements. Represent QA at cross-functional meetings.

· Plan schedules to meet deadlines for product release and prevent gaps or downtime

· Work to ensure a positive experience for customers

· Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health and safety requirements.

· Working knowledge of cGMPs and supporting regulatory documents and apply appropriately.

· Partner with other departments to implement timely procedure changes, based on predetermined specifications.

· Update metric reports for trending.

· Work with personnel to assure that all errors and corrections are resolved according to SOP requirements.

· Identify quality process improvements to increase quality and efficiencies in systems, operations and personnel.

· Submit error free batch records for product shipment.

· Submit Change Requests as needed.

· Support investigations and Corrective Actions/Preventative Actions (CAPAs), including report writing.

· Mentors and provides guidance for less senior QA Batch Record Review Associates.

· Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

· High School diploma or GED, required. Bachelor’s degree in Science, preferred.

· Minimum of 5+ years of experience in a regulated environment (QA, Compliance, Auditing, Laboratory or Inspection, within a GMP environment), required.

· Minimum 1 year prior experience in a leadership role, required.

· Must have strong leadership skills and be able to work within a team and assist in developing others.

· Knowledge and demonstrated understanding of quality assurance principles, controls and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc.

· A high level of technical expertise, ownership and practical knowledge of QA/regulatory programs.

· Strong attention to detail, adherence to SOPs, and demonstrated practical application.

· Demonstrated ability to work effectively in a collaborative environment.

· Demonstrated ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results.

· Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues.

· Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.

· Strong conflict resolution skills.

· Good presentation skills, suitable for management and cross-functional meetings.

· Strong PC Skills Required (MS Word, Excel).

· Demonstrable analytical thinking and problem solving skills.

Physical Environment and Requirements

· Employee must be able to occasionally lift and/or move up to 25lbs.

· Employee must be flexible to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

  • FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
  • Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
  • Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note:

· All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.

· Our recruiting process includes multiple in person and/or video interviews and assessments.

· If you are unsure about the legitimacy of a message, contact John Rossini at [email protected] before responding.

· We never request payment, bank information, or personal financial details during our offer process.

Your security is important to us, and we encourage you to stay vigilant when job searching.

American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email [email protected].

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against American Regent, Inc.'s own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on American Regent, Inc.'s form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    American Regent, Inc.'s answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.