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QA Specialist I - ACM 2nd Shift

PCI Pharma Services · Madison, WI

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Level
Specialist
Team
Quality
Degree
Required (or equivalent experience)
Experience asked
3+ years
Industry
Pharma & life sciences
Posted
25 days ago

The role in 30 seconds

A specialist quality role at PCI Pharma Services (pharma & life sciences) in Madison, WI. Review operator aseptic behavior within the ISO 5 core and adjacent classified areas, and escalate any concerns to the operator or their supervisor.

They ask for
3+ years · degree required (or equivalent experience)
Tools it names
Root cause, FDA / GMP

Read from the posting. The full description is below.

How this role compares

Against 36 other live quality postings in Wisconsin.

Base pay
Not listed in this posting

Typical $77k–$120k, from 12 postings that list pay.

Experience asked
Less than usual (3+ vs 5+)

Similar roles usually ask 5+ years.

Skills these teams ask for most

  • ✓ Root cause 65%
  • Supplier quality 46%
  • SPC 43%
  • FMEA 43%
  • ✓ Team leadership 38%
  • Control plans 38%

✓ = this posting asks for it too. % = share of similar postings that mention it.

Stands out: this posting asks for Union environment, which few similar roles mention. If you have it, lead with it.

It asks for 3+ years. If you're close, apply anyway: requirements are a wish list. Talk to someone on the team first.

At a glance

Pulled from the posting text. If it's not listed here, the posting didn't say.

How to get in at this plant

Five moves over a week or two. The first one takes ten minutes.

  1. 1

    Pick 2–3 people on the Quality team at PCI Pharma Services

    Engineers who joined in the last year or two reply the most. Use the team search on this page to find them.

  2. 2

    Send a short, curious note

    One real question about their work. No favors yet. Each person gets a different note, written for this role.

  3. 3

    Turn a reply into a short call

    Questions worth asking about this team:

    • What does a normal week look like on your team?
    • Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
    • How much of the job is customer complaints versus prevention?
    • How did you land the job? What stood out in your interviews?
  4. 4

    Apply with someone vouching for you

    If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.

  5. 5

    Bring proof to the interview

    One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.

This plant: PCI Pharma Services in Madison

6 other open roles at this site.

Full description from PCI Pharma ServicesAs posted on their careers site.Show

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.

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.
Show full description ↓

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.

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.

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.

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

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