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

Open nowPosted 7 days ago

QA Specialist I - ACM 2nd Shift

pciservices43 open roles

Where
Madison, WI, USA
Get the CV for this job

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

Your applicationOpen nowQA Specialist I - ACM 2nd Shiftpciservices · Madison, WI, USA

  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 pciservices'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.

8.0% of postings close within 7 days. Measured by our own scanner across the market. pciservices postings stay open a median of 2 days.

Share of postings closed within
  1. 1.6%1 day
  2. 3.6%3 days
  3. 8.0%7 days
  4. 15.0%14 days
  5. 34.2%30 days
This job: posted 7 days ago

pciservices median: 2 days open

The posting

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Position Title: Quality Specialist I – ACM

Location: Madison, Wisconsin

Department: Quality Assurance

Reporting To: Supervisor, Quality Assurance Internal Operations

Responsible For (Staff): No

The Quality Specialist I - ACM provides real-time monitoring of aseptic behaviors during sterile manufacturing, including gowning, interventions, environmental monitoring, and material handling in ISO 5/ISO 6 environments. This role supports PCI’s mission of maintaining a high standard of aseptic integrity, product quality, and patient safety.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Review operator aseptic behavior within the ISO 5 core and adjacent classified areas, and escalate any concerns to the operator or their supervisor.
  • Observe and document real-time activities during manufacturing operations, including setup, filling, environmental monitoring, sanitization and routine/corrective interventions.
  • Ensure compliance with PCI aseptic technique expectations, gowning standards, and cleanroom behavior as outlined in SOPs and training.
  • Identify and escalate deviations from aseptic practices, personnel behaviors, or environmental controls that pose potential contamination risks.
  • Capture detailed and objective records of events, interventions, and nonconformances using PCI-approved documentation tools or checklists.
  • Support media fill (aseptic process simulation) operations by providing visual monitoring and feedback throughout the process.
  • Collaborate with Quality Assurance, Operations, Microbiology, and Training to identify opportunities for coaching, retraining, and continuous improvement.
  • Participate in contamination control and environmental monitoring trending to drive site-level improvements and reduce contamination risk.
  • Assist with investigations and root cause analysis for contamination events, EM excursions, and aseptic technique deviations.

QUALIFICATIONS:

Required:

  • High school Diploma, GED, or equivalent credential required, AS degree or BS degree in Life Sciences or related field preferred.
  • 1-3 years of experience in Quality Assurance, aseptic processing, or cleanroom functions within a cGMP‑regulated environment; equivalent combination of education and experience will be considered
  • Ability to learn aseptic techniques, contamination control, and cGMP regulations (21 CFR Parts 210/211, EU Annex 1).
  • Demonstrated ability to observe critically and document behaviors accurately and objectively.
  • Excellent verbal and written communication skills; must be comfortable providing real time coaching.
  • Ability to gown for entry into ISO 5, 6 and 7 cleanroom environments and remain in those areas for extended periods.

Preferred:

  • ​ Proficient in Microsoft Office and electronic quality systems (preferred).
  • Prior experience in a QA or manufacturing oversight role at PCI or a similar aseptic operation is strongly preferred.

#LI-RS1

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

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 pciservices'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 pciservices'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

    pciservices'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.